Oregon Medicaid Fee-For-Service

Division of Medical Assistance Programs Pharmaceutical Services

Prior Authorization Approval Criteria

May 2010

DMAP CAPE 09-396 1109

Division of Medical Assistance Programs (DMAP) Pharmaceutical Service Program

Prior Authorization Approval Criteria

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Division of Medical Assistance Programs Oregon Medicaid Fee-For-Service Prior Authorization Approval Criteria

Table of Contents………………………………………………………………...iii-v

Update Information (What changed?)………………………………………vi-vii

Other Important Documents to use in conjunction with this document: Link to Administrative Rules (Rulebook)/Supplemental Information

General Prior Authorization Information (Excerpts from Supplemental Information)……………………………………....9

Overview……………………………………………………………………...10 Drugs requiring Prior Authorization (PA) DUR Plus review Oregon Pharmacy Call Center review……………………………………. 11 Emergency OA protocol Client hearings and exceptions requests Forms-link only……………………………………………………………… 12

DMAP 3978 Instruction – Pharmacy PA…………………………………. 13

DMAP 3978 Form-DHS PA Request…………………...... 14

Specific Drug PA Information, PA Approval Criteria/contacts…...... 16

Analgesics, Non-Steriodal Anti-Inflammatory Drugs…………………………. 17

Antiemetics, New…………………………………………………………………. 18

Antifungals………………………………………………………………………… 20

Antihistamines…………………………………………………………………….. 24

Antimigraine – Triptans……………………………………………………………26

iii

Anti-Psoriatics…………………………………………………………………….. 28

Antivirals – Topical………………………………………………………………...29

Asthma Controller Drugs………………………………………………………… 31

Benign Prostatic Hypertrophy (BPH) Medications…………………………….. 32

Buprenorphine Sublingual……………………………………………………….. 33

Central Nervous System (CNS): CNS – Sedatives – Benzodiazepine Quantity Limit…………………….. 35

CNS – Sedatives – Non-Benzodiazepine………………………………... 36

CNS – Sedative – Therapeutic Duplication……………………………... 38

CNS – Stimulants…………………………………………………………… 39

Cough and Cold Preparations……………………………………………………42

Dispense As Written-1 (DAW-1) Reimbursement Rate……………………………………………………….43

Exclusion List……………………………………………………………………… 44

Fentanyl Transmucosal and Buccal……………………………………………. 48

Hormones: Growth Hormones………………………………………………………….. 50

Leuprolide…………………………………………………………………… 54

Testosterone………………………………………………………………… 55

Laxatives (Selected Laxatives)………………………………………………….. 56

Leukotriene Inhibitors…………………………………………………………….. 58

Lyrica (Pregabalin)……………………………………………………………….. 60

Marinol (Dronabinol)……………………………………………………………… 62 iv

Milnacipran (Savella)……………………………………………………………... 63

Nasal Inhalers…………………………………………………………………….. 64

Nutritional Supplements (Oral Administration Only)………………………….. 66

Opioids:

Opioids - Long-Acting………………………………………………………. 70

Opioids - Methadone – High Dose Limit…………………………………. 73

Opioids - Narcotic Combination – Excessive dose limits………………. 75

Preferred Drug List (PDL) – Non-Preferred Drugs in Select PDL Classes……………………………. 78

Pegylated Interferon and Ribavirin……………………………………………… 79

Proton Pump Inhibitors (PPI)……………………………………………………. 82

Regranex…………………………………………………………………………... 85

Risperdal Consta – Quantity Edit……………………………………………….. 86

Skeletal Muscal Relaxants………………………………………………………. 87 Tapering Carisoprodal……………………………………………………… 89

Topamax (Topiramate)…………………………………………………………… 90

Weight Loss Medications………………………………………………………… 92

Weight Reduction Questionnaire………………………………………………...94

Oregon Medicaid Fee-For-Service Prior Authorization Approval Criteria Update Information

Effective: April 1, 2010 (corrected 5/1/10)

The Division of Medical Assistance Programs (DMAP) posted this document following the March 18, 2010 meeting of the Drug Utilization Review (DUR) Board with changes effective April 1, 2010. This May 2010 document is updated with the following corrections:

¾ Pages 26, Antimigraine Triptans, Quantity Limits Per Labeling table: added all of the following:

Sumatriptan Sumavel 6 mg SQ 12 mg 6mg/0.5ml units 4 3ml/30d (package of 6)

Sumatriptan/ Treximet 85mg / 170 mg / 85mg/500mg tab 4 9/30d Naproxen 500mg 1000 mg (box of 9)

¾ Page 32, Benign Prostatic Hypertrophy (BPH) Medications, Requires PA: [added] (highlighted/bracketed):

GCN Class Generic Brand

064846 Alpha Blocker [Silodosin] [Rapaflo] [064847]

¾ Page 39, Central Nervous System (CNS) Stimulants, Goals, from the 3rd bullet, we deleted: “The long-term effects of stimulants are unknown. Adverse events are more frequently associated with high doses. However, effectiveness is not linearly associated with dose. and promote preferred drugs in class.”

¾ Page 41, Maximum Recommended Dose Limits for Stimulants: [added] and [corrected]:

HICL 022987 Dexmethylphenidate (>20mg HICL 002065 Dextroamphetamine (>40mg) Brand Strength Daily Brand Strength Daily Limit Limit added [ Focalin XR] [30mg XR cap] [1] corrected [Dexedrine Spansule] 10mg SA cap 4 corrected [Dexedrine Spansule’] 15mg SA cap 2

vi ¾ Page 49, Fentanyl Transmucosal and Buccal, Approval Criteria, #6: [added] (highlighted/bracketed):

6. Is the quantity Yes: Pass to RPH; No: Approve for up to 6 months with quantity limit >4 doses per day? Deny, (Medical of 4 lollipops/tablets per day (i.e. 120/30 days). Appropriateness), with message: etc. [Assessment for dental caries recommended with use of fentanyl transmucosal lozenge (Actiq) due to sugar content.]

¾ Page 82, – Proton Pump Inhibitors (PPI): updated as follows:

Check the reason for the PA request: Non-Preferred drugs will deny on initiation. [Deleted] last sentence Preferred drugs will deny only AFTER initial 60 days in a 365 day period OR initiated at >1 dose QD.

ROUTE HICL BRAND GENERIC FORMULATIONS Oral 008993 Prevacid Lansoprazole [Solu Tab: 15, 30 mg orally disintegrating tablet] Oral 036085 [Kapidex ] Dexlansoprazole Capsules, delayed-release: 30, [Dexilant] 60mg

¾ Page 83, Approval Criteria table – #6 and 8: [deleted] and [added].

6. Has patient tried and failed: Yes: Go to #7. [Go to #12]. [Pass to RPH; Deny, (Cost-effectiveness) Recommend 9 [Prilosec OTC or] Prilosec OTC 20mg QD or BID.] Omepraxole 40mg/day [or [(May approve solutabs or packets for 9 Aciphex 20mg/day] patients with G-tubes, etc.) ]

8. Is diagnosis active GI bleed? Yes: Approve No: Go to #9. [(531.0-531.2, 532.0-532.2, 533.0- for [8] 2 weeks 533.2, 534.0-534.2)] – BID dosing OK

¾ Page 84, #s 9, 10 and 12: [added] 9. Is diagnosis Gastric or Duodenal Ulcer [(531.3-531.9, 531.3-532.9, 533.3-533.9, 534.3- 534.9)] 10. Yes: Approve QD [dosing] for 1 year, etc. [12. Is the request for Prevacid [Yes: Approve QD dosing [No: Pass to RPh. DENY Solutab for tube administration?] for 1 (Cost-effectivenss) year. May approve BID Recommend omeprazole dosing for pediatrics 20mg QD or BID.] <12years old.]

For questions, contact the DMAP Pharmacy Policy at: [email protected]

10-459 5/15/10 vii DMAP provides the information and instructions contained in this booklet to be used in conjunction with current:

Official program policies found in the Billing information found in the Pharmaceutical Services Pharmaceutical Services Rulebook Supplemental Information

Division of Medical Assistance Programs

Pharmaceutical Services Program Pharmaceutical Services

Supplemental information 99 Eligibility verification 99 Point of Sale information 99 ProDUR information 99 Prior authorization information Rulebook 99 Paper billing information 99 Forms and other resources

Includes: January 14, 2010 1) Table of Contents 2) Current Update Information (changes since last update) 3) Other Provider Resource Information 4) Complete set of Pharmaceutical Services Program Administrative Rules

Find both documents here: http://www.dhs.state.or.us/policy/healthplan/guides/pharmacy/main.html General Prior Authorization Information

The following pages 4-7 include information about prior authorization taken from the DMAP Pharmaceutical Services Supplemental Information document found at:

http://www.dhs.state.or.us/policy/healthplan/guides/pharmacy/main.html

Overview For drugs that require prior authorization (PA) on Point-of-Sale (POS) claims:

A new evaluation feature of the Oregon DHS POS system, DUR Plus, reviews incoming POS claims and issues PA when the drug meets appropriate clinical criteria.

For drugs that do not pass DUR Plus review, pharmacies must contact the prescribing provider, who then requests PA from the Oregon Pharmacy Call Center.

Drugs requiring PA

DHS may require PA for individual drugs and categories of drugs to ensure that the drugs prescribed are indicated for conditions funded by the Oregon Health Plan (OHP) and consistent with the Prioritized List of Health Services and its corresponding treatment guidelines (see OAR 410-141-0480 and 0520).

Administrative rule 410-121-0040 is related to drugs requiring prior authorization for Medically Appropriate Use.

For information regarding drugs requiring prior authorization, please refer to the Pharmacy Web site at: www.dhs.state.or.us/policy/healthplan/guides/pharmacy/main.html.

DUR Plus review

The Oregon DHS POS system initially evaluates incoming pharmacy claims for basic edits and audits. If the drug on the claim requires prior authorization (PA) and requires DUR Plus evaluation, the claim passes through a series of clinical criteria rules to determine whether DUR Plus can issue PA and allow dispensing the drug to the client. DUR Plus checks the current drug claim as well as the client’s medical and claims history for the appropriate criteria.

If suitable criteria are found, a prior authorization will be systematically created, applied to the claim, and the claim will be paid. This interactive process occurs with no processing delays and no administrative work for the pharmacy or prescribing provider.

If all criteria are not met, the claim will be denied and PA will be required. The prescriber will be responsible for requesting PA, using procedures outlined in OAR 410-121-0060.

10 Oregon Pharmacy Call Center review

The Oregon Pharmacy Call Center is available 24 hours per day, seven days a week, 365 days a year.

Phone: 888-202-2126 Fax: 888-346-0178

The Call Center receives calls and faxes related to PA requests for fee-for-service prescriptions (including Mental Health “carve-out” prescriptions for managed care clients), and processes PA requests within 24 hours.

Prescribers should use PA procedures outlined in OAR 410-121-0060. For more information, refer to the Pharmacy Web page at www.dhs.state.or.us/policy/healthplan/guides/pharmacy/main.html.

See the Pharmaceutical Services Program Supplemental Information Forms section for forms prescribers should use when submitting PA requests to the Call Center.

Emergency PA protocol

The Oregon Pharmacy Call Center may authorize up to a 96 hour emergency supply. Refer to 410-121-0060(4) Emergency Need:

The Pharmacist may request an emergent or urgent dispensing from the Pharmacy Call Center when the client is eligible for covered fee-for-service drug prescriptions.

(a) Clients who do not have a PA pending may receive an emergency dispensing for a 96-hour supply.

(b) Clients who do have a PA pending may receive an emergency dispensing up to a seven-day supply.

Client hearings and exception requests

For any PA requests that are denied due to DMAP criteria not being met, the right of a client to request a contested case hearing is otherwise provided by statute or rule, including OAR 410-141-0264(10).

This rule describes when a client may request a state hearing. Clients may request a hearing based upon information included in the PA denial notice.

Information on how to file an appeal is attached to all PA notices to clients and providers from the Oregon Pharmacy Call Center.

Providers may contact Provider Services at 800-336-6016 to file an exception request on a PA denial. For information regarding OAR 410-120-1860, refer to the General rules Rulebook at www.dhs.state.or.us/policy/healthplan/guides/genrules/main.html.

Forms

All DMAP forms are available on the web at: www.oregon.gov/DHS/healthplan/forms/omapforms.shtml

DMAP 3978 - Pharmacy Prior Authorization Request

Prescribers should submit their PA requests for fee-for-service prescriptions and oral nutritional supplements with required documentation to: Oregon Pharmacy Call Center 888-202-2126 Fax: 888-346-0178 This form is also available on the DHS Web site at http://dhsforms.hr.state.or.us/Forms/Served/OE3978.pdf.

Information needed to request PA Complete the form as follows. The Oregon Pharmacy Call Center may ask for some or all of the following information, depending upon the class of the drug requested:

DMAP 3978 section Information needed

Section I: Requesting provider name and National Provider Identifier. ¾ FQHC/RHC and AI/AN providers - Also enter the pharmacy or clinic NPI for your facility.

Section II Type of PA Request: Mark “Pharmacy.” ¾ FQHC/RHC and AI/AN providers -Mark “Other,” followed by provider type (FQHC, RHC, IHS or Tribal 638).

Section III: Client name and recipient ID number;

Section IV: Diagnosis code (ICD-9-CM);

Section V: Drug name, strength, size and quantity of medication. ¾ Participating pharmacy: Include the dispensing pharmacy’s name and phone number (if available).

Section VI: Date of PA Request Begin and End Dates of Service

Section VII: Complete for EPIV and oral nutritional supplements only.

Section VIII: Complete for oral nutritional supplements only.

13 For Internal Use Only: PA Number

Prior Authorization Request for Prescriptions & Oral Nutritional Supplements

To: Oregon Pharmacy Call Center 888-346-0178 (fax); 888-202-2126 (phone)

Confidentiality Notice: The information contained in this Prior Authorization Request is confidential and legally privileged. It is intended only for use of the recipient(s) named. If you are not the intended recipient, you are hereby notified that the disclosure, copying, distribution, or taking of any action in regards to the contents of this fax document- except its direct delivery to the intended recipient - is strictly prohibited. If you have received this Prior Authorization Request in error, please notify the sender immediately and destroy all copies of this request along with its contents and delete from your system, if applicable.

Complete all fields marked with an asterisk (*), if applicable. I Requesting Provider * Name * NPI Contact Name Contact Phone - - Contact Fax - - Processing Time Frame: Routine Supporting Justification for Urgent/Immediate Processing: Urgent Immediate

II PA Request - Assignment Code (check appropriate box) * Pharmacy Home EPIV Other

III Client Information * Client ID DOB / / * Last Name * First Name, MI

IV Service Information Estimated length of treatment Frequency Primary diagnosis * Primary ICD-9 diagnosis code Other pertinent diagnosis (For prescriptions and oral nutritional supplements, list all applicable ICD-9 codes or contributing factors)

V Drug/Product Information * Name * Strength * Quantity * NDC Participating Pharmacy: Name Phone Number - - Date / /

VI Date Information * Date of Request / / * Expected Service Begin Date / / * Expected Service End Date / /

Page 1 of 2 DMAP 3978 (7/09) VII Code and Cost Information – Required for EPIV and oral nutritional supplements Line Procedure Total Item Code Modifier Description Units U&C MSRP Dollars 1 2 3 4 5 Total Units VIII Patient Questionnaire – Complete for oral nutritional supplements only Question Yes No Is the patient fed via G-tube? Is the patient currently on oral nutritional supplements? - If Yes, date product started: - How is it supplied (e.g., self-pay, friends/family supply, etc)? Does the patient have Failure to Thrive (FTT)? Does the patient have a long history (more than one year) of malnutrition and cachexia? Does the patient reside in a: - Long-term care facility? - Chronic home care facility? - If Yes, list name of residence: Does the patient have: - Increased metabolic need from severe trauma (e.g., severe burn, major bone fracture)? - Malabsorption difficulties (e.g., Crohn’s Disease, cystic fibrosis, bowel resection/removal, Short Gut Syndrome, gastric bypass, renal dialysis, dysphagia, achalasia)? - A diagnosis that requires additional calories and/or protein intake (e.g., cancer, AIDS, pulmonary insufficiency, MS, ALS, Parkinson’s, cerebral palsy, Alzheimer’s)? Date of last MD assessment for continued use of supplements: Date of Registered Dietician assessment indicating adequate intake is not obtainable through regular or liquefied pureed foods: - Serum Protein level: Date taken: - Albumin level: Date taken: - Current weight: Normal weight: Written Justification and Attachments:

Requesting Physician’s signature:

Page 2 of 2 DMAP 3978 (7/09) Specific Drug Prior Authorization and Contact Information

The following pages include specific drugs, goals or directives in usage, length of authorization, covered alternatives, approval criteria and more.

DMAP prior authorization policy is reviewed by the Oregon Drug Use Review Board (See http://pharmacy.oregonstate.edu/drug_policy/index.php?nav=dur_board and is subject to the DMAP administrative rule writing process.

For general questions about prior authorization policy, contact:

Kathy L. Ketchum, B. S. Pharm., M.P.A.: H.A.

Assistant Director Drug Use Management & Research Program

Contact Information:

OSU College of Pharmacy Drug Use Management & Research Program DHS Division of Medical Assistance Programs 500 Summer Street NE, E-35 Salem, OR 97301-1079 [email protected] Phone: 503-947-5220 Fax: 503-947-1119

Analgesics, Non-Steroidal, Anti-Inflammatory Drugs

Goal(s):

¾ To ensure that non-preferred NSAIDs are used for above the line conditions and restrict ketorolac to short-term use (5 days every 60 days) per the FDA black boxed warning.

WARNING - Ketorolac is indicated for the short-term (up to 5 days) management of moderately severe acute pain that requires analgesia at the opioid level. It is not indicated for minor or chronic painful conditions. Ketorolac is a potent NSAID analgesic, and its administration carries many risks. The resulting NSAID-related adverse events can be serious in certain patients for whom ketorolac is indicated, especially when the drug is used inappropriately. Increasing the dose beyond the label recommendations will not provide better efficacy but will result in increasing the risk of developing serious adverse events.

Initiative: NSAID PDL & Ketorolac Quantity Limit Length of Authorization: Up to 1 year.

Preferred Alternatives: Listed at: http://www.oregon.gov/DHS/healthplan/tools_prov/pdl.shtml

Requires PA: Non-preferred NSAIDs Ketoralac: Maximum of one claim per 60 days. That claim can be a maxiumum of 20 tablets / 5 days, i.e. there is a 5 day maximum per 60 days.

Approval Criteria

1. What is the diagnosis being treated? Document ICD-9

2. Is the diagnosis covered by the Oregon Health Plan? Yes: Go to #3. No: Pass to RPh; All indications need to be evaluated as to whether they are above Deny, the line or below the line. (Not Covered by the OHP)

3. Is this a continuation of current therapy (i.e. filled prescription Yes: Document prior No: Go to #5. within prior 90 days)? therapy in PA record. Go Verify via pharmacy claims. to #4.

4. Is request for ketorolac >20 tablets/5 days, or for > 5 days within Yes: Pass to RPH. Deny No: Go to #5. 60 days? (Medical Appropriateness). Review FDA warnings

5. Will the prescriber consider a change to a preferred product? Yes: Inform provider of No: Approve for 1 Message: covered alternatives in year or length of • Preferred products do not require PA. class. prescription, • Preferred products are evidence-based reviewed for http://www.dhs.state.or.us/p whichever is less. comparative effectiveness & safety by the Health Resources olicy/healthplan/guides/phar Commission (HRC). macy/main.html Reports are available at: http://www.oregon.gov/OHPPR/HRC/Evidence_Based_Reports.shtml.

DUR Board Action: 9/24/09 (DO/KK), 2-23-06 Revision(s): 1/1/10 Initiated: ??

Antiemetics, New

Goal(s):

¾ Promote preferred drugs. ¾ Reserve costly antiemetics for appropriate indications. ¾ Restrict chronic use (> 3 days per week). ¾ If chemotherapy is more frequent than once weekly, approve a quantity sufficient for three days beyond the duration of chemotherapy.

Initiative: Antiemetics (PDL and Quantity Limit) Length of Authorization: 3 days to 6 months (criteria specific)

Preferred Alternatives: Listed at; http://www.oregon.gov/DHS/healthplan/tools_prov/pdl.shtml or metoclopramide (Reglan), prochlorperazine (Compazine), promethazine (Phenergan)

Check the reason for the PA request:

• Non-Preferred drugs will deny on initiation • Preferred drugs will deny only when maximum dose exceeded (www.orpdl.org)

Quantity Limits:

HICL Generic Brand Quantity Limit

025058 Aprepitant Emend 3 doses / 7day

016576 Dolasetron Anzemet 9 doses / 7day

Kytril Tablets 6 doses / 7day 007611 Granisetron Kytril Soln (30 ml liquid)/7

9 doses / 7day 006055 Ondansetron Zofran (300 ml liquid)

019058 Ondansetron Zofran ODT 9 doses / 7day

Approval Criteria next page.

Approval Criteria

1. What is the diagnosis being treated? Record ICD9 code.

2. Is the drug requested preferred? Yes: Go to #4. No: Go to #3.

3. Will the prescriber consider a change to a preferred product? Yes: Inform provider of No: Go to #4. covered alternatives in Message: class and dose limits. If dose > limits, continue to • Preferred products do not require PA for <4 days/week. #4. • Preferred products have received evidence-based reviews http://www.dhs.state.or.us/pol for comparative effectiveness and safety by the Health icy/healthplan/guides/pharma Resources Commission (HRC). cy/clinical.html

http://www.oregon.gov/OHPPR/HRC/Evidence_Based_Reports.shtml

4. Is client currently diagnosed with cancer AND receiving Yes: Approve for 3 days No: Go to #5. chemotherapy or radiation therapy more frequently than every 7 past length of therapy. days? (Chemo regimen more frequently than weekly)

5. Does client have refractory nausea that would require Yes: Go to #6. No: Go to #8. hospitalization or ER visits?

6. Has client tried and failed two conventional antiemetics, listed below?

Yes: Approve up to 6 No: Go to #7. Generic Name Brand Name months. metoclopramide Reglan

prochlorperazine Compazine promethazine Phenergan

7. Does client have contraindications to conventional antiemetics, Yes: Document reason No: Pass to RPH; Go e.g. Allergy; or cannot tolerate? and approve up to 6 to #8. months. (Contraindications to Required Alternative Medications)

Above: Deny, 8. RPH only All other indications need (Medical to be evaluated as to Appropriateness) whether they are above the line or below the line. Below: Deny, (Not Covered by the OHP)

DUR Board Action: 9-24-09(DO/KK), 2-23-06, 2-24-04, 11-18-03, 9-9-03, 5-13-03, 2-11-03 Revision(s): 1-1-10, 7-1-06, 3-20-06, 6-30-04 (added aprepitant), 3-1-04 (removed injectables), 6-19-03 Initiated: 4-1-03

Antifungals

Goal(s): Approve use of antifungals only for covered diagnoses.Minor fungal infections of skin, such as dermatophytosis of nail and skin are only covered when complicated by an immunocompromised host.

Length of Authorization: SEE CRITERIA ORAL Covered Alternatives: Griseofulvin DOES NOT require prior authorization and other oral antifungals NOT typically used for onychomycosis DO NOT require PA:

Generic Name Brand Name Fluconazole Diflucan Flucytosine Ancobon Ketoconazole Nizoral Nystatin Mycostatin Viconzaole Vfend Requires PA: HSN Route Generic Name Brand Name Oral antifungals commonly used for onychomycosis. 006503 ORAL Itraconazole Sporanox 007590 ORAL Terbinafine Lamisil

TOPICAL

Preferred Alternatives: GCN Generic Name Brand Name(s) Miconazole topical 007366, 047965 cream Micatin, others Nystatin topical 007282, 007283 ointment & cream Mycostatin

NOT Covered: (See EXCLUSION LIST): Gentian Violet HIC3 - Q5F Castellani Paint HIC3 – L9A Requires PA: Topical Antifungals (HIC3 = Q5F) Examples (NOT ALL INCLUSIVE) of TOPICAL ANTIFUNGALS requiring PA and FDA approved indications: T. T. T. Pedis/ T. Pityriasis Cutaneous Seborrheic Atopic Lichenoid Generic Name Brands Corporis Cruris mannum Unguium versicolor candidiasis dermatitis dermatitis dermatitis Amphotericin B Fungizone X Lotrimin ultra; Butenafine HCL mentax X X X X Ciclopirox Loprox, penlac X X X X X X X Clotrimazole Lotrimin; Mycelex X X X X Clotrimazole/ Betamet Diprop Lotrisone X X X X Econazole Nitrate Spectazole X X X X X Ketoconazole Nizoral X X X X X X X X X Naftifine HCL Naftin X X X X X Nystatin/Triamcin Mycolog II X Oxiconazole nitrate Oxistat X X X X X Sertaconazole nitrate Ertaczo X Sulconazole nitrate Exelderm X X X X Terbinafine hcl Lamisil & at (rx & otc) X X X X Tolnaftate (otc) Tinactin X X X Undecylenic acid (otc) Desenex X X X 20 Table 1 – Examples of COVERED indications (1/1/06) ICD-9 Description 112.1 Candidiasis of vulva and vagina 112.2 Candidiasis of other urogenital sites 112.4 Candidiasis of the lung 112.5 Disseminated Candidiasis 112.81 Candidal Endocarditis 112.82-112.89 Candidal Otitis Externa - Other Candidiasis site 114.0-114.9 Coccidiomycosis various sites 115.00-115.99 Histoplamosis 116.0-116.2 Blastomycosis Rhinosporidosis, Sporotrichosis, Chromoblastomycosis, Aspergillosis, Mycotis Mycetomas, Cryptococcosis, Allescheriosis, 117 & subsets Zygomycosis, Dematiacious Fungal Infection, Mycoses Nec and Nos 118 Mycosis, Opportinistic 518.6 Bronchopulmonary Aspergillus, Allergic 616 & subsets Inflammatory disease of cervix vagina and vulva 681 & subsets Cellulitis and abscess of finger and toe 771.7 Neonatal Candida infection

Table 2 – Examples of NOT-COVERED conditions (1/1/06) ICD-9 Description 690 & subsets Erythematosquamous dermatosis 691 Atopic dermatitis and related conditions 691.0 Diaper or napkin rash 691.8 Other atopic dermatitis and related conditions 692 & subsets Contact dermatitis and other eczema 695.2-695.4 Erythema nodosum, rosacea, lupus erythematosus Other specified erythematous conditions, erythematous cond nec, 695.8-695.9 unspecified erythematous condition 697 & subsets Lichen 706 & subsets Diseases of sebaceous glands 111 Dermatomycosis nec/nos 111.0 Pityriasis versicolor 111.2 Tinea blanca 111.3 Black piedra 111.8 Dermatomycoses nec 111.9 Dermatomycosis nos 112.3 Cutaneous candidiasis 112.9 Candidiasis site nos 782.1 Nonspecif skin erupt nec

Table 3 – Criteria Driven diagnoses (1/1/06) ICD-9 Description 110 Dermatophytosis 110.0 Dermatophytosis of scalp and beard (tinea capitis/ tinea barbae) 110.1 Dermatophytosis of nail (onychomycosis) 110.2 Dermatophytosis of hand (tinea manuum) 110.3 Dermatophytosis of groin and perianal area (tinea cruris) 110.4 Dermatophytosis of foot (tinea pedis) 110.5 Dermatophytosis of body (tinea corporis / tinea imbricate) 110.6 Deep seated dermatophytosis 110.8 Dermatophytosis of other specified sites 110.9 Dermatophytosis site of unspecified site 111.1 Tinea nigra 112.0 Candidosis of mouth

Approval Criteria

1. Is the diagnosis in Table 1, Examples of Yes: approve as follows: (Above the line diagnosis) No: Go to #2.

COVERED indications (1/1/06)? ORAL

• Toenails = 12 weeks. Max of 1 course per yr.

• Fingernails = 6 weeks. Max of 1 course every 6 months.

ORAL & TOPICAL • All other diagnosis = Course of treatment only with prn renewals. • If length of therapy is unknown, approve for 3 months

2. Is the diagnosis in Table 2, Examples of NOT- Yes: Pass to RPH; Deny, (Not Covered by the No: Go to #3. COVERED conditions (1/1/06)? OHP).

3. Is the diagnosis in Table 3, Criteria Driven Yes: Go to #4. No: Go to #6. diagnoses (1/1/06)?

4. Is the client immunocompromised? Document Yes: approve as follows: (Immunocompromised No: Go to #5. ICD-9 code client) • Does the client have a current (not history of) ORAL diagnosis of cancer AND is currently • undergoing Chemotherapy or Radiation? Toenails = 12 weeks. Max of 1 course per yr. • Document therapy and length of treatment. Fingernails = 6 weeks. Max of 1 course every OR 6 months. • Does the client have a diagnosis of ORAL & TOPICAL HIV/AIDS? OR • All other diagnosis = Course of treatment only • Does client have diagnosis of diabetes that with prn renewals. requires anti-diabetic medications e.g. • If length of therapy is unknown, approve for 3 Insulin, metformin, glyburide, or any drug in months the therapeutic class of Diabetic Therapy? Document medication(s). OR • Does client have sickle cell anemia?

5. Is client currently taking an Yes: approve as follows:(Immunocompromised No: Pass to immunosuppressive drug? Document drug. client) RPH; Deny, Immunosuppressive drugs include but are not (Not Covered limited to: ORAL by the OHP) • Toenails = 12 weeks. Max of 1 course per yr. • Fingernails = 6 weeks. Max of 1 course every Generic Names: Brand Names: 6 months. ORAL & TOPICAL Azathioprine Imuran • All other diagnosis = Course of Basiliximab Simulect treatment only with prn renewals. Cyclosporine Sandimmune, Neoral • If length of therapy is unknown, approve Sirolimus Rapamune for 3 months Tacrolimus Prograf Methotrexate (Mtx) Rheumatrex Hydroxychloroquine Plaquenil Etanercept Enbrel Leflunomide Arava

If not in list, Pass to RPH for evaluation.

6. RPH only: All other indications need to be evaluated to see if they are above or below the line diagnosis:

• If above the line fungal code, then it may be approved for treatment course with prn renewals. If length of therapy is unknown, approve for 3 months intervals only • If below the line: Deny, (Not Covered by the OHP). • Deny Non-fungal diagnosis (Medical Appropriateness) • Deny Fungal ICD-9 codes that do not appear on the OHP list pending a more specific diagnosis code (Not Covered by the OHP). • Forward any fungal ICD-9 codes not found in the Tables 1, 2, or 3 to the Lead Pharmacist. These codes will be forwarded to DMAP to be added to the Tables for future requests.

DUR Board Action: 2-23-06; 11-10-0; 9-15-05; 5-12-05 Revision(s): 7-1-06; 11-1-0; 9/1/0 Initiated:

Antihistamines

Goal(s):

¾ Approve antihistamines only for covered diagnosis.

¾ Allergic rhinitis treatment is covered by the OHP only when complicated by other diagnoses (e.g. asthma, sleep apnea).

¾ Promote use that is consistent with Oregon Asthma Guidelines and medical evidence. Http://www.oregon.gov/DHS/ph/asthma/pubs.shtml#oregon

Length of Authorization: 6 months

Preferred Alternatives: Oral corticosteroid inhalers, certirizine, chlorpheniramine, diphenhydramine, loratidine & hydroxyzine DO NOT require prior authorization. See: http://www.oregon.gov/DHS/healthplan/tools_prov/pdl.shtml

PA Required: All drugs (antihistamines and combinations) in TC = 14, except those listed above and including, but not limited to, the following:

Drug Code Brand Name Generic Name HSN= 011595 Allegra Fexofenadine HCL HSN= 016846 Allegra D Fexofenadine/Pseudoephedrine HCL HSN= 006605 Allergy Relief-D Loratadine/Pseudoephedrine Sulfate HSN= 004483 Brompheniramine Maleate HSN= 024112 Brompheniramine Tannate HSN= 004483 Carbinoxamine Maleate

HSN= 026664 Carbinoxamine Tannate HSN= 021934 Clarinex Desloratadine HSN= 006605 Claritin-D Loratadine/Pseudoephedrine Sulfate HSN= 004512 Clemastine Fumarate HSN= 001672 Cyproheptadine HCL HSN= 004506 Dexchlorpheniramine Maleate HSN= 013225 Diphenhydramine Citrate HSN= 001608 Hydroxyzine HCL

HSN= 006605 Loratadine - D Loratadine/Pseudoephedrine Sulfate

HSN= 008959 Semprex-D Acrivas/Pseudoephedrine HCL HSN= 022959 Xyzal Levocetirizine

Approval Criteria

1. What is the diagnosis being treated? Record ICD9 codes.

Does client have diagnosis of allergic 2. Yes: Go to #3. No: Go to #7. rhinitis, allergic conjunctivitis, or chronic rhinitis/pharyngitis/nasophrynigitis? (ICD-9: 472.xx, 372.01-05, 372.14, 372.54, 372.56, 477.xx, 995.3, V07.1)

Does the client have asthma or reactive 3. Yes: Go to #4. No: Go to #5. airway disease exacerbated by chronic/allergic rhinitis or allergies (493.xx)?

4 Does the drug profile show an asthma Yes: Approve for 6 No: Pass to RPH; controller medication (e.g. ORAL inhaled months. Deny, (Medical Appropriateness) steroid, leukotriene antagonist, etc.) And/or Oregon Asthma guidelines recommend all asthma rescue beta-agonist (e.g. Albuterol) within clients have access to rescue inhalers and those the last 6 months? with persistent disease should use anti- inflammatory medicines daily (preferably orally Keep in mind: albuterol may not need to be inhaled steroids). used as often if asthma is controlled on other medications.

oes client have other co-morbid 5. D Yes: Document ICD-9 No: Pass to RPH; conditions or complications that are above codes and Go to #6. Deny, (Not Covered by the OHP) the line? • Acute or chronic inflammation of the orbit (376.0 – 376.12) • Chronic Sinusitis (473.xx) • Acute Sinusitis (461.xx) • Sleep apnea (327.20,327.21,327.23- 327.29,780.51, 780.53, 780.57) • Wegener’s Granulomatosis (ICD- 446.4)

Does client have contraindications (e.g. 6. Yes, Approve 6 months No: Pass to RPH; Deny, (Cost-Effectiveness) Pregnant), or had insufficient response to available alternatives? Document

Is the diagnosis COPD(496) or 7. Yes: Pass to RPH; No: Go to #8. Obstructive Chronic Bronchitis (491.1- Deny, (Medical 491.2) Appropriateness). Antihistamine not indicated

Is the diagnosis Chronic Bronchitis 8. Yes: Pass to RPH; No: Pass to RPH; Go to #9. (491.0, 491.8, 491.9)? Deny, (Not Covered by

the OHP).

9. RPH only: Is the diagnosis above the line or below the line?

• Above: Deny, yesterday’s date (Medical Appropriateness) • Below: Deny, (Not Covered by the OHP). (e.g., URI-465.9 or Uticaria-708.0, 708.1. 708.5, 708.8, and 995.7 should be denied)

Refer questions regarding coverage to DMAP.

DUR Board Action: 9-18-08reh, 2-23-06, 9-14-04, 5-25-04, 2-10-02, 5-7-02 Last Revision(s): 7/1/09, 7-1-06, 3-20-06, 10-14-04, 8-1-02, 9/1/06 Initiation:

Antimigraine - Triptans

Goal(s):

¾ Decrease potential for Medication Overuse Headache through quantity limits and therapeutic duplication denials. ¾ Promote PDL options. See DUR Board Newsletter: http://pharmacy.oregonstate.edu/drug_policy/pages/dur_board/newsletter/articles/volume5/5_6.pdf

Initiative: Anti-migraine PDL, Quantity Limits & Duplicate Therapy.

Length of Authorization: up to 6 months

Preferred Alternatives: See PDL options: http://www.oregon.gov/DHS/healthplan/tools_prov/pdl.shtml

Check the reason for PA request:

• Non-Preferred drugs will deny on initiation • Preferred drugs will deny only when maximum dose exceeded • Both will deny for concurrent therapy (Concurrent triptans by different routes is allowed.i.e. oral + nasal, oral + injectable, nasal + Injectable)

Quantity Limits Per Labeling

Generic Brand Initial dose Max. Daily Dosage form Max # Limit dose has/Mth Almotriptan Axert 6.25-12.5 mg 25 mg 4 12/45d 6.25 mg tab Rpt in 2hr 12.5 mg tab (blister pack, 6, 12)

20 mg tab Eletriptan Relpax 20–40 mg 80 mg 3 12/60d 40 mg tab Rpt in 2hr (blister pack, 6, 12)

Frovatriptan Frova 7.5 mg 2.5 mg tab 4 9/30d 2.5-5 mg (blister pack, 9) Rpt in 2hr

1-2.5 mg 1 mg tab 9/30d Naratriptan Amerge 5 mg 4 Rpt in 4hr 2.5 mg tab (blister pack, 9)

Rizatriptan Maxalt 5-10 mg 30 mg 4 12/30d 5 mg tab Maxalt Rpt in 2hr 10 mg tab (blister pack, 6, 12) MLT

25 mg tab, 50mg tab, Sumatriptan Imitrex & 25-100 mg po rpt 200 mg 4 9/30d 100 mg tab (blister pack, 9) generics In 2 hr

5 mg, 10 mg NS 5-10 mg NS 40 mg 4 6/30d (box of 6) Rpt in 2 hr

6 mg SQ (box 2 syr), 3-6 mg SQ 12 mg 4 6/30d kit (2 syr per kit), Rpt in 2hr 3mls/30d 6mg/0.5ml vials

Sumatriptan Sumavel 6 mg SQ 12 mg 6mg/0.5ml units 4 3ml/30d (package of 6)

Sumatriptan Treximet 85mg / 500mg 170 mg / 85mg/500mg tab 4 9/30d / Naproxen 1000 mg (box of 9)

Zomitriptan Zomig 1.25-5 mg 10 mg 2.5 mg tab 3 6/30d (blister pack, 6) Zomig Rpt in 2hr

ZMT 5 mg tab

(blister pack, 3) Zomig 5mg NS 10mg NS Rpt in 2hr 5mg NS (box of 6) 4 6/30d 26

Approval Criteria

1. What is diagnosis being treated? Record ICD9 code.

2. Does patient have diagnosis of migraine, ICD- Yes: Go to #3 No: Pass to RPH, 9 346.0-346.9? Deny, (Medical Appropriateness) There is no evidence to support the use of triptans for non- migraine diagnoses.

3. Is drug requested preferred? Yes: Go to #5. No: Go to #4.

4. Will the prescriber consider a change to a Yes: Inform provider of covered No: Go to #5. preferred product? alternatives in class and dose limits.

Message: http://www.dhs.state.or.us/policy/healt hplan/guides/pharmacy/main.html • Preferred products do not require PA within recommended dose limits. • Preferred products are evidence-based reviewed for comparative effectiveness & safety by the Health Resources Commission (HRC).

Reports are available at: http://www.oregon.gov/OHPPR/HRC/Evidence_B ased_Reports.shtml.

5. Is request for higher dose than listed in Yes: Pass to RPH; Deny, (Medical No: Trouble-shoot quantity limit chart? Appropriateness) claim payment (days supply?); • Can recommend use of migraine Go to #6. prophylactic therapy and reinforce that doses above those recommended by the manufacturer increase the incidence of medication overuse headache (may refer to DUR Board Newsletter above). • One life-time 90-day taper may be approved at pharmacist discretion. • Document.

6. Is the request for two different oral triptans Yes: Go to #7. No: Approve for 6 concurrently? months

7. Is this a switch in triptan therapy due to Yes: Document reason for switch and No: Go to #8. intolerance, allergy or ineffectiveness? override for concurrent use for 30 days.

8. Does patient request more triptan due to Yes: Document reason and approve for No: Pass to RPH, supply lost or stolen or a vacation/travel supply? date of service. (Medical Appropriateness). There is no evidence to support the use of two different ORAL triptans concurrently.

DUR Board Action: 3/18/10(KK)9/24/09(DO/KK)11-18-03, 5-13-03 Initiation: 6/30/04 Revision(s): 3/23/10,1/1/10, 7-1-06, 5-31-05 27

Anti-Psoriatics

Goal(s): Cover topical anti-psoriatics only for covered OHP diagnoses. Moderate/Severe psoriasis treatments are covered on the OHP. Treatments for mild psoriasis (696.1-696.2, 696.8), seborrheic dermatitis (690.XX), keroderma (701.1-701.3) and other hypertrophic and atrophic conditions of skin (701.8, 701.9) are not covered.

Length of Authorization: 1 year

Preferred Alternatives: Topical corticosteroids, methotrexate, cyclosporin Requires PA: TC = 92 and HIC = L1A, L5F, L9D, T0A

TC HIC3 Name of drug Brand 92 Coal tar (Various) L1A Acitretin / emollient comb no.26 Soriatane ck L1A Methoxsalen, rapid Oxsoralen-ultra L1A Methoxsalen 8-mop L5F Anthralin Psoriatec; drithocreme hp L5F Calcipotriene Dovonex L5F Tazarotene Avage, tazorac L9D Methoxsalen Oxsoralen lotion T0A Betamet diprop / calcipotriene Taclonex T0A Betamet diprop / calcipotriene Taclonex scalp

Approval Criteria

1. What is the diagnosis being treated? Record ICD9 code

2. Is the diagnosis for seborrheic dermatitis Yes: PASS TO RPH - Deny (Not No: Go to #3. (690.XX), keroderma (701.1-701.3) or other Covered by the OHP). hypertrophic and atrophic conditions of skin (701.8, 701.9)

3. Is the diagnosis Psoriasis? Yes: Go to #4. No: Go to #5. ( ICD-9: 696.1-696.2, 696.8)

4. Is the Psoriasis Moderate/Severe? Defined Yes: Approve for length of No: PASS TO RPH Deny as: treatment or 1 year. (Not Covered by the At least 10% body surface area involved or OHP). with functional impairment.

5. RPH only If above the line or clinic If below the line: Deny, All other indications need to be evaluated as to provides supporting literature: (Not Covered by the whether they are above the line or below the approve for length of treatment. OHP). line diagnosis.

DUR Board Action: 9/24/09 (klk), 3/19/09(klk), 2/26/06, 5/24/07 Revision(s): 1/1/10, 7/1/09, 6/1/07 Initiated: 9-1-06

Antivirals – Topical

Goal(s):

¾ Cover topical anti-virals only for covered diagnoses.

¾ HSV infections are covered only when complicated by an immunocompromised host.

Antivirals –Topical Length of Authorization: Criteria Specific

Covered Alternatives: Oral acyclovir DOES NOT require PA

Requires PA: HIC3 = Q5V HSN GENERIC BRAND ROUTE 004183 Acyclovir Zovirax Topical 011636 Penciclovir Denavir Topical 021956 Docosanol Abreva Topical

Approval Criteria

1. What is the diagnosis? Record the ICD9 codes.

2. Is the diagnosis uncomplicated herpes Yes: Go to #3. No: Pass to RPH; Go to #6. simplex (not genital) ICD9: 054.2, 054.6, 054.73, 054.9?

3. Is the client immunocompromised? Yes: Approve for 1 year No: Go to #4. Document ICD9 code: (Immunocompromised Client) • Is client currently (not history of) diagnosed with Cancer AND currently undergoing chemotherapy or radiation? Document therapy and treatment regimen. • Does client have diagnosis of HIV/AIDS?

4. Is client currently taking an Yes: Approve for expected No: If Diabetes or Sickle-Cell disease- immunosuppressive drug? Document drug: therapy duration or 90 days. go to #5. All others go to #6. (Immunocompromised Client) (If drug not in list below, Pass to RPH for evaluation)

Immunosuppressive drugs include, but are not limited to:

Generic Names Brand Names

Azathioprine Imuran Basiliximab Simulect Cyclosporine Sandimmune, Sirolimus Neoral Tacrolimus Rapamune Methotrexate Prograf Hydroxychloroquine (MTX) Rheumatrex Etanercept Plaquenil Leflunomide Enbrel Arava

5. Does client have Diabetes or Sickle- Cell disease? Yes: Pass to RPH; Deny, (Not No: Pass to RPH to evaluate for Covered by the OHP). immunosuppression. Note: Diabetes and Sickle-Cell is not considered as immunocompromisng for ¾ If not immunocompromised, antivirals as it is for antifungals. Deny (Not Covered by the OHP).

¾ If immunocompromised, approve for 1 year.

6. RPH only:

All other indications need to be evaluated to see if they are above or below the line diagnosis:

• If above, viral diagnoses can be approved for treatment course with “prn” renewals. If length of therapy is unknown, please approve for 3 months intervals only (This is an exception to above guidelines and should be discussed with Lead Pharmacist)

• If below, Deny, (Not Covered by the OHP).

• Deny Non-viral diagnoses (Medical Appropriateness).

• Deny Viral ICD-9 codes that do not appear on the OHP list pending a more specific diagnosis code. (Not Covered by the OHP)

Refer questions of coverage to DMAP.

DUR Board Action: 2-26-06, 2-21-01, 9-6-00 Revision(s): 9-1-06,

Asthma Controller Drugs

Goal(s): The purpose of this prior authorization policy is to ensure that non-preferred asthma controller drugs are used for an above the line condition.

Initiative: Asthma Controller PDL Length of Authorization: up to 1 year

Preferred Alternatives: Listed at: http://www.oregon.gov/DHS/healthplan/tools_prov/pdl.shtml

Approval Criteria

1. Is the requested drug montelukast (Singular)? Yes: Go to Leukotriene No: Go to #2. Inhibitor Criteria

2. What is the diagnosis? Record ICD9 code.

3. Is this an OHP covered diagnosis? Yes: Go to #4. No: Pass to RPh, DENY (Not Covered by the OHP).

4. Is this a continuation of current therapy (i.e. filled Yes: Document prior therapy No: Go to #5. prescription within prior 90 days)? in PA record. Approve for 1 Verify via pharmacy claims. year.

5. Will the prescriber consider a change to a preferred Yes: Inform provider of covered No: Approve for 1 year product? alternatives in class. or length of Message: prescription, whichever - Preferred products do not require PA. http://www.orpdl.org is less. - Preferred products are evidence-based reviewed for comparative effectiveness & safety by the Health Resources Commission (HRC). Reports are available at: http://www.oregon.gov/OHPPR/HRC/Evidence_Based_Reports.shtml

DUR Board Action: 9/24/09(DO), 5/21/09 Revision(s): 1/1/10 Initiated: 1/1/10

Benign Prostatic Hypertrophy (BPH) Medications

Goal(s):

¾ BPH with urinary obstruction treatment is covered by OHP only when post-void residuals are at least 150ml.

¾ Cosmetic use for baldness is NOT covered.

Length of Authorization: 1 year

Covered Alternatives: Generic terazosin, doxazosin and prazosin available without PA;

Requires PA:

GCN Class Generic Brand

045052 Alpha Blocker Alfuzosin Uroxatral 027546 Alpha Blocker Tamsulosin Flomax 064846 Alpha Blocker Silodosin Rapaflo 064847 037050 5-alpha reductase inhibitor Finasteride Propecia 041440 5-alpha reductase inhibitor Finasteride Proscar 051246 5-alpha reductase inhibitor Dutasteride Avodart

Approval Criteria

1. What is the diagnosis? Record ICD9 code.

2. Is the request for an alpha blocker, and does client have a Yes: Go to #3. No: Go to #4. diagnosis related to functional and mechanical disorders of the genitourinary system including bladder outlet obstruction? (592.1, 595.1, 596.0, 596.3-596.5, 596.54, 596.7-596.9, 598, 599.82-599.89)

3. Has the client tried and failed a 2-month trial of a covered Yes: Approve an Alpha No: Deny until client alternative alpha blocker (terazosin, doxazosin, prazosin)? Blocker only for 1 year has tried and failed a covered alternative

4. Does client have a diagnosis of BPH (Benign Prostatic Yes: Approve for 1 year No: Go to #5. Hypertrophy) or enlarged prostate with obstruction? (600.01, 600.11, 600.21, and 600.91; 788.2 + 600.xx see RPH notes)

5. Does client have a diagnosis of unspecified urinary obstruction or Yes: Pass to RPH; No: Pass to RPH; Go benigh prostatic hyperplasia without obstruction? (599.6, 600.00, Deny, (Not Covered by to #6. 600.10, 600.20, and 600.90) the OHP).

6. RPH Notes only - All other indications need to be evaluated to see if they are above or below the line:

• Above the line covered diagnoses related to prostate may be approved for 1 year

• Below the line diagnoses (e.g. Hair growth) should be denied (Not Covered by the OHP).

• Alpha Blockers and 5-alpha reductase inhibitors (ARI) may be used concurrently for BPH up to 1 year. Alpha- blockers may be discontinued once prostate is reduced to normal size.

• 788.2 (retention of urine, obstructive); Ask for more specific diagnosis. If along with 600.01, 600.11, 600.21 or 600.91, then may approve.

Refer questions of coverage to DMAP.

DUR Board Action: 3/18/10(KK), 5-22-08, 2-23-06 Revision(s): 4/20/10, 5-22-08 (Aebi), 7-1-06, 9-30-05 Effective: 10-14-04 (previously excluded) 32

Buprenorphine Sublingual Goal(s):

¾ Expand access to opioid addiction treatment. ¾ Treatment of pain remains a priority, including e.g. addicts with injury & illness. Buprenorphine would need to be held during opioid treatment, esp. long-acting opioids.

Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, TIP 40, available at http://www.samhsa.gov or http://www.ncbi.nlm/nih.gov/books/bv.fcgi?rid=hstat5

Length of Authorization: up to 6 months; 2 months if MD prescribing for immediate need pending cerification. Requires PA:

GCN Brand Generic

051640 Suboxone buprenorphine/naloxone 051641

029312 Subutex buprenorphine 029313

Approval Criteria

1. What is the diagnosis being treated? Record ICD9 code

2. Is diagnosis one of the following?: Yes: Go to #3. No: Pass to RPH; Deny for medical 304.00 Opioid type dependence unspecified use appropriateness. 304.01 Opioid type dependence continuous use 304.02 304.70 Combinations of opioid type drug with other drug dependence unspecified use

304.71 Combinations of opioid type drug with any other drug dependence continuous.

3. Is prescriber a Physicans Assistant or Nurse Yes: Pass to RPH. No: Go to #4. Practitioner? (NPs & PAs may not prescribe.) Deny for medical appropriateness.

4. Does prescribing physician have a Drug Addiction Yes: Document number or No: Go to #5. attach copy of the SMASHA Treatment Act (DATA)-2000 waiver ID number (also request to PA record. Go to termed a special X-DEA license or certification)? #6. OR

Prescriber provides copy of SAMSHA certification request pending with “Immediate Need” checked? (Once MD meets criteria SAMHSA may take 45 days to process.)

Note: Physicians do not have to list their license on the SAMHSA Buprenorphine Physician Locater web site, which is publicly available. Pharmacists may call the Buprenorphine Information Center at 1-866-BUP-CSAT to verify unlisted or application under review prescribers.

33 No: Pass to RPH; Deny for 5. Does MD qualify for waiver from separate Yes: Go to #6. medical appropriateness. registration?

Encourage physician to get ¾ Must have a valid DEA license, AND training & register at ¾ Board certified in addiction medicine, OR SAMSHA ¾ Employed by an opioid treatment program, OR http://buprenorphine.samhs ¾ Federally employed physicians (e.g. IHS or VA) a.gov/howto.html or FAX “intent” form to 240- 276-1630 at DEA.

6. Is patient concurrently on long-acting opioids (check Yes: Pass to RPH. No: Go to #7. claim record & inform prescriber of any current claims)? Deny for medical

appropriateness. Examples of long-acting opioids include: methadone (e.g. Dolophine, Methadose) DO NOT GIVE methadone, levodromoran or any long-acting opiate long-acting morphine (e.g. MS Contin, Oramorph SR, CONCURRENTLY with Kadian, Avinza) buprenorphine. If currently long-acting oxycodone (e.g. OxyContin) on methadone, reduce to fentanyl patches (e.g. Duragesic) stable state of 30 mg Opana XR methadone equivalent (methadone 40 = buprenorphine 6mg), then wait 24 hours to initiate buprenorphine

7. Is patient concurrently on other opioids (check claim Yes: Pass to RPH. Deny for No: Go to #8. record & inform prescriber of any current claims in STC medical appropriateness. 40)? If MD can provide rationale for concurrent therapy document in PA record & continue to #8.

8. Is dose < 24 mg / day (may average every other day Yes: Go to #9. No: Pass to RPH. DENY. therapy, i.e. 48mg qod). Deny for medical appropriateness.

If MD can provide rationale, document in PA record & continue to #9.

9. What is patient’s pharmacy of choice? Inform prescriber patient will be locked in to a single ¾ Document pharmacy name & NPI or address in pharmacy for all prescriptions. Go to #10. PA record. ¾ Lock patient into their pharmacy of choice for 6 months. ¾ Use reason code: Suboxone.

10. What is the expected length of treatment? a) If Prescriber is waiting for SAMSHA certification Document treatment length in PA record. (#3) subsequent approvals dependent on certification: Approve x 2months. b) If Prescriber is certified (#3): Approve for anticipated length of treatment or 6 months, whichever is shorter.

DUR Board Action: 9/24/09 (REH),5/21/09, 9/24/09 Revision(s): Initiated: 1/1/10

Central Nervous System (CNS) Sedatives - Benzodiazepine Quantity Limit

Goal(s): ¾ Approve only for covered OHP diagnoses. ¾ Treatment of uncomplicated insomnia is not covered, but insomnia contributing to covered comorbid conditions is. ¾ Prevent adverse events associated with long-term sedative use. ¾ Clients coming onto the plan on chronic sedative therapy are grandfathered.(refer to criteria). Also see related Sedative Therapy Duplication edit. The safety and effectiveness of chronic sedative use is not established in the medical literature. There is a documented increased risk of serious adverse events in the elderly. See DUR Board Newsletter: http://pharmacy.oregonstate.edu/drug_policy/pages/dur_board/newsletter/articles/volume8/DURV8I1.html and Http://pharmacy.oregonstate.edu/drug_policy/pages/dur_board/newsletter/articles/volume3/3_2.htm#chronic

Length of Authorization: 6 months to 1 year, (criteria specific) Covered Alternatives: Zolpidem (NDC’s priced as generic), trazodone, mirtazapine, diphenhydramine or tricyclic antidepressants may be alternatives for some clients.

TC HSN GENERIC BRAND

47 001592 Temazepam Restoril 47 001593 Flurazepam HCL Dalmane Requires PA: Quantity Exceeding Limit of 15 doses / 30 days 47 001594 Triazolam Halcion 47 001595 Quazepam Doral 47 006036 Estazolam Prosom

Approval Criteria

1. What is the diagnosis being treated? Record the ICD9 code

Does client have diagnosis of insomnia with sleep 2. Yes: Go to #3. No: Go to #4. apnea, ICD9: 780.51?

3. Is client on CPAP? Yes: Approve for up to 1 No: PASS TO RPH, DENY year. The use of CPAP (Medical appropriateness). Due essentially negates the to the depressant effects of sedative contraindication and sedative/ hypnotics, they are often prescribed to sedative/hypnotics are help clients cope with the contraindicated for this diagnosis mask. and are not approvable.

4. Is the client being treated for co-morbid depression, anxiety, bipolar disorder or panic (i.e. Is there an existing claim history of antidepressants, Yes: Approve for up to 1 year No: PASS TO RPH, Go to #5. lithium, antipsychotics, or other appropriate mental health drugs)?

5. RPH only: Is diagnosis being treated a covered Above: Document supporting indication on the OHP and is there medical evidence literature and approve up to 6 of benefit of the prescribed sedative? All indications months with subsequent Below: Go to #6. need to be evaluated as to whether they are above approvals dependent on f/u the line or below the line. and documented response.

6. RPH only: Is this a request for continuation therapy Yes: Document length of for client with history of chronic use where No: DENY (Medical treatment and last follow-up discontinuation would be difficult or unadvisable? Appropriateness) date. Approve for up to 1 NOTE: Clients coming onto the plan on chronic sedative therapy are “grandfathered.” year.

DUR Board Action: 5-18-06, 2-23-06, 11-10-05, 9-15-05, 2-24-04, 2-5-02, 9-7-01 Revision(s): 1-1-07, 7-1-06, 11-15-05 Initiated: 11-15-02 35

Central Nervous System (CNS) - Sedative Non-Benzodiazepines

Goal(s):

¾ Approve only for covered OHP diagnoses.

¾ Treatment of uncomplicated insomnia is not covered; insomnia contributing to covered co-morbid conditions is.

¾ Prevent adverse events associated with long-term sedative use. Clients coming onto the plan on chronic sedative therapy (continuously for >90) are “grandfathered.” (Refer to criteria).

• See related Sedative Therapy Duplication edit. The safety and effectiveness of chronic sedative use is not established in the medical literature. There is a documented increased risk of serious adverse events in the elderly.

• See DUR Board Newsletter: http://pharmacy.oregonstate.edu/drug_policy/pages/dur_board/newsletter/articles/volume8/DURV8I1.html and • Http://pharmacy.oregonstate.edu/drug_policy/pages/dur_board/newsletter/articles/volume3/3_2.htm#chronic

Length of Authorization: 6 months to 1 year, (criteria specific)

Covered Alternatives: ¾ Zolpidem (NDC’s priced as generic)

¾ Trazodone May be alternatives for ¾ Mirtazapine some clients. ¾ Diphenhydramine ¾ Tricyclic antidepressants

Benzodiazepine sedatives are available for short-term (15 doses/30days) without PA.

Requires PA: TC HSN GENERIC BRAND 47 007842 ** Ambien, Ambien CR, Ambien PAK 47 020347 Zaleplon Sonata 47 026791 Eszopiclone Lunesta 47 033126 Ramelteon Rozerem * Quantity Limit edit does not apply to Non-Benzodiazepines **for HSN 007842, GCNs 019187 and 019188 are exceptions

Approval Criteria

1. What is the diagnosis? Record the ICD9 code.

Does client have diagnosis of insomnia 2. Yes: Go to #3. No: Go to #4. with sleep apnea, ICD9: 780.51?

Yes: Approve for up to 1 year. No: Pass to RPH; Deny, (Medical The use of CPAP essentially appropriateness). negates the sedative Sedative/hypnotics, due to 3. Is client on CPAP? contraindication and they are depressant effect, are contraindicated often prescribed to help clients for this diagnosis and are not cope with the mask. approvable.

4. Is the client being treated for: 9 Co-morbid depression, 9 Anxiety, 9 Bipolar disorder or 9 Panic

Yes: Approve for up to 1 year No: Pass to RPH; Go to #5. (i.e. Is there an existing claim history of: 9 Antidepressants, 9 Lithium, 9 Antipsychotics, or 9 Other appropriate mental health drugs)?

5. RPH only: Is diagnosis being treated a covered indication on the OHP and is there medical evidence of benefit of the Above: Document supporting prescribed sedative? literature and approve up to 6 Below: Go to #6. months with subsequent All indications need to be evaluated as to approvals dependent on f/u and see if they are above the line or below the documented response. line.

6. RPH only: Is this a request for continuation therapy for client with history of chronic use where discontinuation would be difficult or unadvisable? Yes: Document length of treatment and last follow-up date. No: Deny, (Medical Appropriateness) NOTE: Clients coming onto the plan on Approve for up to 1 year. chronic sedative therapy are “grandfathered.”

DUR Board Action: 5-18-06, 2-23-06, 11-10-05, 9-15-05, 2-24-04, 2-5-02, 9-7-01 Revision(s): 1-1-07, 7-1-06, 11-15-05 Initiated: 11-15-02

Central Nervous System (CNS) – Sedatives- Therapeutic Duplication

Goal(s):

¾ Prevent duplicate sedative use.

¾ Approve only for covered OHP diagnoses.

¾ Treatment of uncomplicated insomnia is not covered; insomnia contributing to covered comorbid conditions is.

¾ Also see related Benzo Quantity edit and Non-benzo Sedative edit. ¾ The safety and effectiveness of chronic sedative use is not established in the medical literature. There is a documented increased risk of serious adverse events in the elderly. See DUR Board Newsletter: http://pharmacy.oregonstate.edu/drug_policy/pages/dur_board/newsletter/articles/volume8/DURV8I1.html and http://pharmacy.oregonstate.edu/drug_policy/pages/dur_board/newsletter/articles/volume3/3_2.htm#chronic

Length of Authorization: 1 month

Covered Alternatives: ¾ Trazodone ¾ Mirtazapine May be alternatives for some clients. ¾ Diphenhydramine ¾ Tricyclic antidepressants

Requires PA: The plan prohibits the client from receiving two oral sedative medications at the same time. POS system screens duplicate oral sedative claims in the prior 30 days. If client has a covered diagnosis, treatment with any single agent is approvable.

Benzodiazepine sedatives, zolpidem & zaleplon in TC=47 TC HSN GENERIC BRAND 47 001592 Temazepam Restoril 47 001593 Flurazepam HCL Dalmane 47 001594 Triazolam Halcion 47 001595 Quazepam Doral 47 006036 Estazolam Prosom 47 007842 Zolpidem Ambien, Ambien CR, Ambien PAK 47 020347 Zaleplon Sonata 026791 Eszopiclone Lunesta 033126 Ramelteon Rozerem

Approval Criteria

1. What is the diagnosis being Record the diagnosis, ICD9 code and reject the internal error code treated?

No: Pass to RPH; Deny, (Medical appropriateness). 2. Is this a switch in sedative therapy Yes: Document reason There is no evidence to support the use of two due to intolerance, allergy or for switch and approve different sedatives concurrently. Continuous use of a ineffectiveness? duplication for 30 days. single sedative is approvable for covered diagnoses. (See benzo quantity limit sedative and non-benzo PA)

DUR Board Action: 5-18-06 Revision(s): Initiated: 1/1/07

Central Nervous System (CNS) – Stimulants

Goal(s):

¾ Cover stimulants only for OHP covered diagnoses (e.g. ADHD, narcolepsy).

¾ Restrict to doses supported by medical literature and promote preferred drugs in class.

¾ The long-term effects of stimulants are unknown. Adverse events are more frequently associated with high doses. However, effectiveness is not linearly associated with dose.

Initiative: CNS Stimulants (Non-PDL & Excessive Dose)

Length of Authorization: 1 month, 2 month or 1 year, (criteria specific)

Check the reason for PA request:

• Non-Preferred drugs will deny on initiation. • Preferred drugs will deny only when maximum dose is exceeded. • When a PA is entered, clients are locked into the per day quantity we enter in our PA. If the dose is increased, claims will reject for “plan limitations”. If that happens and the client is still meeting criteria, then end the old PA and enter a new one with the updated directions.

Preferred Alternatives: Listed at: http://www.oregon.gov/DHS/healthplan/tools_prov/pdl.shtml

PA does NOT concern drugs in STC 07 or 11, however, these drugs are not to be encouraged. The State is prohibited from prior authorizing Class 11 drugs by statute. These include: • armodafinil (Nuvigil) • atomoxetine (Strattera) • modafanil (Provigil)

Approval Criteria

1. What diagnosis is the stimulant being used to treat? Record ICD9 code

2. Is diagnosis one of the following?: ADHD (ICD9 314-314.01); Yes: Go to #4. No: Go to #3. Narcolepsy (ICD9 341) Drug-induced sedation (ICD9 292.89)?

3. Is the diagnosis above the line? No: Pass to RPH; Deny, Yes: Go to #4. Unspecified hypersomnia (ICD9 780.54) and Obesity treatment (Not Covered by the OHP) (278.0 - 278.1) are below the line..

4. Is drug requested preferred? Yes: Go to #7. No: Go to #5.

5. Is this continuation of therapy (claim indicating prescription Yes: Document prior No: Go to #6. filled within prior 90 days)? prescription drug & date in PA record. Go to #7.

6. Will the prescriber consider a change to a preferred product? Yes: Inform provider of No: Go to #7. Message: covered alternatives in class • Preferred products do not require PA for FDA approved doses. and dose limits. • Preferred products are evidence-based reviewed for comparative effectiveness & safety by the Health Resources http://www.dhs.state.or.us/ Commission (HRC). /policy/healthplan/guides/ Pharmacy/main.html Reports are available at: http://www.oregon.gov/OHPPR/HRC/Evidence_Based_Reports.shtml

7. Is dose greater than limits in table below? Yes: Go to #8. No. Approve for up to 1 year.

8. Is the prescriber a psychiatrist? Yes: Approve for up to 1 year No: Go to #9.

9. Is the patient < 18 years old? Yes: Go to #10. No: Pass to RPH; Deny, (Medical Appropriateness) Dose exceeds maximum recommended dose

10. How much does the patient weigh? Document patient’s weight and continue to #11.

Yes: Pass to RPH; No: Approve for up 11. Is the patient receiving an accumulative dose that EXCEEDS Deny. (Medical to 1 year. 2mg/kg/day of methylphenidate products or EXCEEDS Appropriateness) - Dose 0.5mg/kg/day of amphetamine products? exceeds maximum recommended dose. Consider switching to an alternative stimulant drug class or assessing compliance with the current therapy.

Additional Criteria for Pharmacists:

If a client does not meet criteria and has been established on high doses (long term use), then:

1. A 1-month PA may be entered to allow time for the provider to collect the necessary information (i.e. patient’s weight). 2. A 2-month PA may be entered to allow the physician to taper the patient down to acceptable doses. 3. If neither #1 nor #2 is acceptable to the prescriber, a 1-month PA may be entered; refer them for provider reconsideration and Medical Director review.

See Maximum Recommended Dose Limits for Stimulants next page.

MAXIMUM RECOMMENDED DOSE LIMITS FOR STIMULANTS

HICL 001682 Methylphenidate (>90mg) HICL 013449 Mixed Amphetamine Salts (>60mg)

Brand Strength Daily Brand Strength Daily Limit Limit Adderall 5 mg tab 12 Methylin/Ritalin 5mg tab 18 Adderall 10mg tab 6 Methylin/Ritalin 10mg tab 9 Adderall 20mg tab 3 Methylin/Ritalin 20mg tab 4 Adderall 30mg tab 2 Metadate ER, Methylin ER, Ritalin SR 20mg ER/SR tab 4 Adderall 7.5mg tab 8 Metadate ER, Methylin ER 10mg ER tab 9 Adderall 12.5mg tab 5 Metadate CD 10mg CD cap 9 Adderall 15mg tab 4 Metadate CD 20mg CD cap 4 Adderall XR 10mg XR cap 6 Metadate CD 30mg CD cap 3 Adderall XR 20mg XR cap 3 Metadate CD 40mg CD cap 2 Adderall XR 30mg XR cap 2 Metadate CD 50mg CD cap 1 Adderall XR 5 mg XR cap 12 Metadate CD 60mg CD cap 1 Adderall XR 15mg XR cap 4 Ritalin LA 10mg LA cap 9 Adderall XR 25mg XR cap 2 Ritalin LA 20mg LA cap 4 Ritalin LA 30mg LA cap 3 Ritalin LA 40mg LA cap 2 HICL 002065 Dextroamphetamine (>40mg) Brand Strength Daily Concerta 18mg tab 5 Limit Concerta 27mg tab 3 Dexedrine Spansule 5mg SA cap 8 Concerta 36mg tab 2 Dexedrine Spansule 10mg SA cap 4 Concerta 54mg tab 1 Dexedrine Spansule 15mg SA cap 2 Methylin 2.5mg chew tab 36 Dexedrine 5mg/5ml elixir 40mls Methylin 5mg chewable tab 18 Dextrostat/Dexedrine 5mg tab 8 Methylin 10mg chewable tab 9 Dextrostat 10mg tab 4 Dextrostat 15mg tab 2 Methylin 5mg/5ml soln. 90mls Methylin 10mg/5ml soln. 45mls HICL 034486 Lisdexamfetamine (>70mg) Brand Strength Daily HICL 022987 Dexmethylphenidate (>20mg Limit Brand Strength Daily Vyvanse 20mg 2 Limit Vyvanse 30mg 2 Focalin 2.5 mg tab 8 Vyvanse 40mg 1 Focalin 5mg tab 4 Vyvanse 50mg 1 Focalin 10mg tab 2 Vyvanse 60mg 1 Focalin XR 5mg XR cap 4 Vyvanse 70mg 1 Focalin XR 10mg XR cap 2 HICL 033556 Methylphenidate transdermal (>30mg Focalin XR 20mg XR cap 1 Brand Strength Daily Limit Focalin XR 30mg XR cap 1 Daytrana 10 mg 1 HICL 002067 Methamphetamine (>60mg) Daytrana 15 mg 1 Desoxyn 5mg tab 12 Daytrana 20 mg 1 Desoxyn 10mg tab 6 Daytrana 30 mg 1 Desoxyn 5mg SA tab 12 Desoxyn 10mg SA tab 6 Desoxyn 15mg SA tab 4

DUR Board Action: 3/18/10 (DO) 9-24-09 (DO), 12-4-08 (reh), 2-23-06, 11-10-05, 9-15-05, 5-12-05, 2-21-01, 9-6-00, 5-10-00

Revision(s): 04/26/2010(DO),12/16/09,1-1-10, 7-1-06, 2-23-06, 11-15-05 Initiated:

Cough and Cold Preparations

Goal(s):

¾ Limit use of cough and cold preparations to covered diagnoses.

¾ Symptomatic treatment of upper respiratory tract infections is not covered by the OHP.

Length of Authorization: 1 year

Covered Alternatives: These generic preparations DO NOT require prior authorization:

HSN DRUG NAME (GENERIC) 000271 Guaifenesin 000206 Guaifenesin/Codeine PHOS 000223 Guaifenesin/D-methorphan HB 002091 Pseudoephedrine HCL

PA Required: All drugs (antihistamines and combinations) in TC = 16, 17 except those listed above. TC 16 = Cough Preparations/ Expectorants TC 17 = Cough and Cold Preparations

Approval Criteria

1. What is the diagnosis? Record ICD9 code.

2. Is the diagnosis an OHP covered diagnosis? All Yes: Above the No: Below the line diagnosis: indications need to be evaluated to see if they are line diagnosis: Pass to RPH; Deny, (Not Covered covered diagnoses on the Oregon Health Plan list of Go to #3. by the OHP). prioritized services. Http://egov.oregon.gov/DAS/OHPPR/HSC/current_prior.s Offer alternatives html

3. Has the client tried and failed or are they Yes: document No: Pass to RPH; Deny, contraindicated to one of the covered alternatives listed failure. Approve (Cost Effectiveness) above? for one year.

DUR Board Action: 2-23-06 Last Revision(s): Initiated: 1-10-08

Dispense As Written-1 (DAW-1) Reimbursement Rate Brand Name and Multi-source Goal(s):

¾ State compliance with US CFR 42 Ch.IV §447.512 ¾ Encourage use of generics. ¾ Cover multi-source brand drugs at the higher reimbursement rate (DAW-1) only when diagnosis is covered by OHP and medically necessary.

Length of Authorization: 1 year

Covered Alternatives: Prior Authorization is NOT required when multi-source brands are dispensed with DAW codes other than DAW-1 and thus pay at State Maximum Allowable Cost (SMAC) or Federal Upper Limits (FUL) reimbursement rates.

SMAC and/or FUL are applied only when two or more A-rated generics are available from a manufacturer that participates in the Federal rebate program. SMAC and FUL prices and dispute forms are listed at: http://www.dhs.state.or.us/policy/healthplan/guides/pharmacy/billing.html

Requires PA: All multi-source drugs dispensed with a DAW-1 code (except narrow therapeutic index drugs listed below) as defined in ORS 414.325.

NO PA Required:

Narrow-therapeutic Index Drugs that WILL PAY Without Prior Authorization

HSN Generic Name Brand Name(s) 001893 Carbamazepine Tegretol 004834 Clozapine Clozaril 004524 Cyclosporine Sandimmune 010086 Cyclosporine, modified Neoral 000004 Digoxin Lanoxin 002849 Levothyroxine Levothroid, Synthroid 008060 Pancrelipase Pancrease 001879 Phenytoin Dilantin 002812 Warfarin Coumadin 008974 Tacrolimus Prograf 000025 Theophylline controlled-release Various HIC3-C4G Insulin(s) Various

Approval Criteria: What is the diagnosis being treated with the branded drug?

1. Is the diagnosis an OHP (DMAP) above the line Yes: Go to #2. No: Pass to RPH; Deny diagnsosis? (Not Covered by the OHP). Offer alternative of using generic or pharmacy accepting generic price (no DAW-1)

2. Is the drug requested an antiepileptic in Std TC 48 Yes: Document prior use No: Go to #3. (e.g. Lamotrigine) or immunosuppressant in Spec TC and approve for one year. Z2E (e.g. Cellcept) and is the client stabilized on the branded product?

3. Does client have documented failure (either Yes: Document date used No: Pass to RPH; Deny, therapeutic or contraindications) on an AB-rated and results of trial. (Cost Effectiveness) generic? (usually 2 weeks is acceptable) Approve for one year.

DUR Board Action: 2-23-06, 3-19-09, 12/3/09 (KK) Revision(s): 7-1-06, 9-08, 7/1/09 (KK), 1/1/10 (KK) Initiated: 6-16-03 43

Exclusion List

¾ Deny payment for drug claims for drugs that are only FDA-approved for indications that are not covered by the Oregon Health Plan.

¾ Other exclusionary criteria are in rules at: http://www.dhs.state.or.us/policy/healthplan/guides/pharmacy/main.html.

Excerpt from OAR 410-121-0147 Exclusions and Limitations (DMAP Pharmaceutical Services Program)

The following items are not covered for payment by the Division of Medical Assistance Programs (DMAP): (1) Drug Products for diagnoses below the funded line on the Health Services Commission Prioritized List; (2) Home pregnancy kits; (3) Fluoride for individuals over 18 years of age; (4) Expired drug products; (5) Drug Products from Non-Rebatable Manufacturers; (6) Drug products that are not assigned a National Drug Code (NDC) number; (7) Drug products that are not approved by the Food and Drug Administration (FDA); (8) Drug products dispensed for Citizen/Alien-Waived Emergency Medical client benefit type; (9) DESI drugs (see OAR 410-121-0420); (10) Medicare Part D covered drugs or classes of drugs for fully dual eligible clients;…

NOTE: Returns as “70 – NDC NOT COVERED”

Approval Criteria

1. What is the diagnosis? Record the ICD9 code.

2. For what reason is it being rejected?

2A. “70” NDC Not Covered Yes: Go to the Medicare B initiative in these No: Go to #2B. (Transaction line states “Bill criteria. Medicare”

2B. “70” NDC Not Covered Yes: Informational Pa to bill specific agency No: Go to #2C. (Transaction line states “Bill Medicare or Bill Medicare D”

2C. “70” NDC Not Covered (due to Yes: Informational PA with message “The drug No: Go to #2D. expired or invalid NDC number) requested does not have a valid National Drug Code number and is not covered by Medicaid. Please bill with correct NDC number.”

2D. “70” NDC Not Covered (due to Yes: Informational PA (Need to billed via DME No: Go to #2E. DME items) (Error code M5 –requires billing rules) manual claim) 1-800-336-6016

2E. “70” NDC Not Covered Yes: Pass to RPH, Deny, (Non-Rebatable No: Go to #2F. (Transaction line states “Non- Drug) with message Rebatable Drugs” ) “The drug requested is made by company that does not participate in Medicaid Drug Rebate Program and is therefore not covered”

2F. “70” NDC Not Covered Yes: Pass to RPH, Deny, (DESI Drug) with No: Pass to RPH. Go to (Transaction line states “DESI Drug”) message, #3. “The drug requested is listed as a “Less-Than- Effective Drug” by the FDA and not covered by Medicaid.”

3. RPH only: “70” NDC Not Covered Above: Deny, yesterday’s date (Medically Below: Deny, (Not (Drugs on the Exclusion List) All Appropriateness) and use clinical judgment to Covered by the OHP) indications need to be evaluated to APPROVE for 1 month starting today to allow see if they are above the line or time for appeal. Message: “The treatment below the line. for your condition is not a Message: “Although the request has been covered service on the denied for long term use because it is Oregon Health Plan.” considered medically inappropriate, it has also been APPROVED for one month to allow time for appeal.”

If the MAP desk notes a drug is often requested for a covered indication, notify Lead Pharmacist so that policy changes can be considered for valid covered diagnoses.

See: Exclusion list next page.

45 Exclusion List Drug Code Description DMAP Policy

DCC = 1 Drugs To Treat Impotency/ Impotency Not Covered on OHP List Erectile Dysfunction DCC = B Fertility Agents Fertility Treatment Not Covered on OHP List

DCC = D Diagnostics DME Billing Required

DCC= F, except HSN = 018751 002111 Weight Loss Not Covered on OHP List except In 002112 Weight Loss Drugs cases of co-morbidity. Exceptions are Prior 002070 Authorized 002113 016924

DCC= Y Ostomy Supplies DME Billing Required

HIC3= B0P Inert Gases DME Billing Required Hypertrichotic Agents, HIC3= L1C Systemic/Including Cosmetic Indications Not Covered on OHP List Combinations HIC3= Q6F Contact Lens Preparations Cosmetic Indications Not Covered on OHP List

HIC3=X1C Iud’s DME Billing Required

HIC3=D6C Alosetron Hcl IBS Not Covered on OHP List

HIC3=D6E Trgaserod IBS Not Covered on OHP List

HIC3=L1D Hyperpigmentation Agents

HIC3=L3P Astringents

HIC3=L4A Topical Antipruritic Agents

HIC3=L5A; Except HSN= Acne, Warts, Corns/Calluses; Seborrhea Are Keratolytics 002466 Not Covered on OHP List 006081 (Podophyllin Resin)

Cosmetic Indications, Acne, Atopic Dermatitis, HIC3=L5B Sunscreens Warts, Corns/Callouses; Diaper Rash, Seborrhea Are Not Covered on OHP List

Cosmetic Indications, Acne, Atopic Dermatitis, HIC3=L5C Abrasives Warts, Corns/Callouses; Diaper Rash, Seborrhea Are Not Covered on OHP List

HIC3=L5E Anti Seborrheic Agents Seborrhea Not Covered on OHP List

HIC3=L5G Acne Agents Acne Not Covered on OHP List

HIC3=L5H Acne Agents, Topical Acne Not Covered on OHP List

HIC3=L6A; Except HSN = 002577 Acne, Atopic Dermatitis, Seborrhea, Sprains Not Irritants 002576 Covered on OHP List 002574 002572 (Capsaicin)

HIC3=L7A Shampoos Cosmetic Indications, Seborrhea, Not Covered on OHP List

HIC3=L8A Deodorants Cosmetic Indications Not Covered on OHP List

HIC3=L8B Antiperspirants Cosmetic Indications Not Covered on OHP List

Exclusion List (cont.)

Drug Code Description DMAP Policy

Cosmetic Indications, Acne, Atopic Dermatitis, Warts, Corns/Callouses; HIC3=L9A Topical Agents, Misc Diaper Rash, Seborrhea, are Not Covered on OHP List

HIC3=L9B Vit A Used for Skin Acne Not Covered on OHP List

HIC3=L9C Antimelanin Agents Pigmentation Disorders Not Covered on OHP List

HIC3=L9D Topical Hyperpigmentation Agent Pigmentation Disorders Not Covered on OHP List

HIC3=L9F Topical Skin Coloring Dy Agent Cosmetic Indications Not Covered on OHP List

HIC3=L9I Topical Cosmetic Agent; Vit A Cosmetic Indications Not Covered on OHP List

HIC3=L9J Hair Growth Reduction Agents Cosmetic Indications Not Covered on OHP List

HIC3=Q5C Topical Hypertrichotic Agents Cosmetic Indications Not Covered on OHP List

HIC3=Q5K Topical Immunosuppressants Atopic Dermatitis Not Covered on OHP List

Antihistamine-Decongestant, Allergic Conjunctivitis Not Covered Vasoconstrictor and Mast Cell HIC3=Q6R, Q6U, Q6D on OHP List Eye Drops

Herbal Supplements “ Natural Anti-Inflammatory Supplements” HIC3= U5A, U5B, U5F & - Not Including Nutritional S2H plus HSN= 014173 Supplements such as: Ensure, Boost, Etc.

HSN = 004045 + Clindaminycin Topical Acne Not Covered on OHP List ROA = TOPICAL Sulfacetamide Sodium/Sulfur HSN=003344 Acne Not Covered on OHP List Topical

HSN=008712, 004022 + Erythromycin Topical Acne Not Covered on OHP List ROA=TOPICAL

HSN=025510 Rosac Acne Not Covered on OHP List

TC = 93; Cosmetic Indications, Acne, Atopic Dermatitis, Warts, Corns/Callouses; Except HSN = Emmolients/Protectants 002363 (dextranomer) Diaper Rash, Seborrhea, Psoriasis Are Not Covered on OHP List 002361 (zno)

DUR Board Action: 2-23-06 Revision(s): 9/1/06 Initiated: 10-01-04

47 Fentanyl Transmucosal and Buccal

The purpose of this prior authorization policy is to ensure that Actiq/Fentora/Onsolis is appropriately prescribed in accordance to FDA black box warning:

• “Actiq/Fentora/Onsolis is indicated only for the management of breakthrough cancer pain in clients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

• Clients considered opioid tolerant are those who are taking at least 60 mg morphine/day, 50 mcg transdermal fentanyl/hour, or an equianalgesic dose of another opioid for a week or longer.

• Because life-threatening hypoventilation could occur at any dose in clients not taking chronic opiates, Actiq/Fentora/Onsolis is contraindicated in the management of acute or postoperative pain.

• This product must not be used in opioid non-tolerant clients. Actiq/Fentora/Onsolis is intended to be used only in the care of cancer clients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

• When prescribing do not convert patients from other fentanyl products on a mcg per mcg basis. Pharmacokinetic differences between products could cause fatal over dose.

• Caution should be used when combining Actiq/Fentora/Onsolis with CYP3A4 inhibitors. Increases in fentanyl concentrations could cause fatal respiratory depression.

• Patients and their caregivers must be instructed that Actiq/Fentora/Onsolis contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all units out of the reach of children and to discard opened units properly.”

Initiative: MAP: Actiq/Fentora

Length of Authorization: Up to 6 months (w/qty limit)

Covered Alternatives: Generic morphine solutions and hydromorphone, morphine or oxycodone tablets DO NOT require PA.

The following requires PA:

GSN GENERIC BRAND

022358, 022360, 041339, Fentanyl Citrate Actiq 041340, 041341, 041342

061492, 061493, 063177, Fentanyl Citrate Fentora 061495, 061496, 061497

65552, 65553, 65554, Fentanyl Citrate Onsolis 65555, 65556

Approval Criteria

1. What is the diagnosis for which Actiq/Fentora/Onsolis is being Record ICD9 code and reject/internal error requested? code

2. Is the pain diagnosis above the line Above the line: go to Below the line: No, Pass to RPH; or below the line? (for DMAP, #3. Deny, (Not Covered by the OHP). Actiq/Fentora/Onsolis is not limited to cancer pain but must be severe chronic pain)

3. Is the prescriber an oncologist or Yes: Go to #4. No: Pass to RPH; Deny, pain specialist? (Medical Appropriateness), with message:

“The described use is not consistent with the FDA labeling which Actiq/Fentora/Onsolis be used only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.”

4. Is client tolerant to opioids (Check Yes: Go to #5. No: Pass to RPH; Deny, profile), defined as chronic long- (Medical Appropriateness), with message: acting opioid dose of: • Morphine greater than 60 mg “Your request was reviewed and denied per day? OR because it is not consistent with the FDA • Transdermal fentanyl 50 mcg labeling. A trial of immediate release per hour? OR morphine or oxycodone is recommended • Equianalgesic dose of prior to use of Actiq/Fentora/Onsolis.” another opioid for at least one week?

5. Has the client tried and failed Yes: Go to #6. No: Pass to RPH; Deny, immediate release morphine or (Medical Appropriateness), with message: oxycodone? OR is the client allergic, unable to swallow or intolerant to “Your request was reviewed and denied morphine and oxycodone? based on the following: A trial of immediate release morphine or oxycodone is recommended prior to use of Actiq/Fentora/Onsolis.”

6. Is the quantity >4 doses per day? Yes: Pass to RPH; No: Approve for up to 6 months with Deny, (Medical quantity limit of 4 lollipops/tablets per day Appropriateness), with (i.e. 120/30 days). message: Assessment for dental caries “Your request for a recommended with use of fentanyl quantity greater than 4 transmucosal lozenge (Actiq) due to sugar has been denied content. because it exceeds limits.”

DUR Board Action: 3/18/10(DO); 12-3-09 (KS), 9-15-05, 5-12-05 Revision(s): 4/26/10 (DO), 4/1/08, 6/1/08, 1/1/10 Initiated: 9-1-06

Hormones – Growth Hormone (Somatrem, Somatropin)

Goal(s): Cover drugs only for covered diagnoses and those where there is medical evidence of effectiveness and safety.

Length of Authorization: 3 months, 1 year, 2 years, lifetime (criteria specific)

Note: Criteria is divided into: →Pediatric (<18 years old) • New therapy • Renewal therapy

→Adult (>18 years old) • New therapy • Renewal therapy

→AIDS wasting • New therapy • Renewal therapy

Requires PA: All drugs in HIC3 = P1A

Brand Generic FDA Indications Dosing Accretropin Somatropin GHD, Turner Daily recombinant Genotropin Somatropin GHD, PWS, SGA, AGHD, Turner Daily Genotroptin Miniquick Humatrope Somatropin GHD, Turner, AGHD, ISS, SHOX Daily Norditropin Somatropin GHD, AGHD, Turner, Noonan Daily

Nutropin; Nutropin AQ; Somatropin GHD, CRI, ISS, Turner, AGHD Daily Norditropin Nordiflex Nutropin Depot Somatropin GHD Monthly Omnitrope Somatropin GHD, AGHD Daily recombinant Saizen Somatropin GHD, AGHD Daily Serostim Somatropin AIDS wasting Daily TEV-Tropin Somatropin GHD 3 times / week Zorbtive Somatropin Short Bowl Syndrome Daily

Pediatric Approval Criteria (<18 years old) - New Therapy

1. Is this a request for initiation of growth hormone? Yes: Go to question #2. No: Go to renewal therapy

2. Is the prescriber a pediatric endocrinologist or pediatric Yes: Document and go to #3. No: Pass to RPH; Deny, nephrologist? (Medical Appropriateness)

3. What is the diagnosis being treated? Record ICD9 code and reject/internal error code go to #4.

4. Is the diagnosis one of the following? Yes: Document and go to #5. No: Go to #4a. • Growth hormone deficiency (GHD) (253.2 – 253.5) • Turner’s Syndrome (758.6) • Noonan Syndrome (759.89) • Pre-transplant chronic renal insufficiency (CRI) (593.9) • Prader - Willi Syndrome(PWS) (759.81) • Neonatal Hypoglycemia associated with Growth Hormone Deficiency

4.a. Is the diagnosis: promotion of growth delay in a child Yes: Document and send to No: Deny, (medical rd with 3 degree burns (ICD-9 codes 941.3-949.3)? DHS Medical Director for appropriateness) review and pending approval

5. If male, is bone age <16 years? Yes: Document and go to #6. No: Pass to RPH; Deny, If female, is bone age <14 years? (Medical Appropriateness)

6. Is there evidence of non-closure of epiphyseal plate? Yes: Document evidence and No: Pass to RPH; Deny, approve for one year either (Medical (Child –Growth Failure) OR Appropriateness) Female –Turner’s Syndrome if applicable

Pediatric Approval Criteria (<18 years old) – Renewal Therapy

1. Document approximate date of initiation of therapy and diagnosis ( if not already done).

2. Is growth velocity greater than 2.5 cm per year? Yes: Document and No: Pass to RPH; Deny, go to next question. (Medical Appropriateness)

Yes: Approve for one No: Pass to RPH; Deny, 3. Is male bone age <16 yrs. And year. Document either (Medical Appropriateness) Is female bone age <14 yrs.? (Child –Growth

Failure) OR Female – Turner’s Syndrome if applicable

Adult Approval Criteria (> 18 years old) - New Therapy

1. What is the diagnosis? Record ICD9 code being treated.

2. Is diagnosis hypothalamic or pituitary disease? Yes: Go to #3. No: Go to next table (AIDS waisting)

3. Is this a request for initiation of growth hormone Yes: Go to. #4. No: Go to renewal criteria treatment?

4. Is GHD due to a destructive lesion of the pituitary or Yes: If complete No: Pass to RPH; Deny, peri-pituitary area, (for example, pituitary adenoma), or as hypopituitarism/panhypopitui (Medical Appropriateness) a result of treatment, such as cranial irradiation, or tarism, document and go to surgery? #6. Otherwise, document and go to.#5.

5. Does client have a provocative stimulation test < 5 Yes: Document and go to No: Pass to RPH; Deny, ng/ml if measured by radioimmunoassay or < 2.5 ng/ml if #6. (Medical Appropriateness) measured by immunoradiometric assay? The insulin tolerance test is the preferred testing method, but other secretagogues, such as arginine, GHRH, and L- dopa are acceptable. Clonidine is not acceptable.

6. Is client receiving full supplementation of deficient Yes: Document and go to No: Pass to RPH; Deny, pituitary hormones, such as thyroid, glucocorticoids, or #7. (Medical Appropriateness) gonadotropic hormones?

7. Does client have at least ONE of the following Yes: Approve for 2 Years No: Pass to RPH; Deny, abnormalities or elevated risk factors associated with GH (Adult-Pituitary Insufficiency (Medical Appropriateness) deficiency, as evidenced by one of the following: with Appropriate Testing) (Document in notes) • Reduced bone mineral density (BMD) of greater than 1 SD below the mean, using the WHO criteria? OR • High risk lipid profile (total cholesterol level >240mg/dl, or LDL level >190mg/dl) OR • At least 2 pituitary hormone deficiencies (other than GH), such as TSH, ACTH, gonadotropins, or ADH.

Adult Approval Criteria (> 18 years old) - Renewal Therapy (Required annually to check for therapy benefit)

At 2 years client must show improvement in their Document the ONE that client used as qualifier in

original qualifying risk factor as compared to original approval. baseline; subsequent renewals must show

maintenance of gains.

Has there been: Yes: Document Approve for 1 No: Pass to RPH, DENY • Increase in bone mineral density (BMD) per year (Adult-Pituitary (Medical DEXA scan? OR Insufficiency with Appropriate Appropriateness) • At least a 5% reduction in lipid panel OR Testing)

If client has: Yes: Document and Approve No: Pass to RPH; Deny, • 2 pituitary hormone deficiencies no BMD or lipid for lifetime (12-31-2036) (Medical (Adult-Pituitary Insufficiency Appropriateness) 52 panel required with Appropriate Testing)

Approval Criteria (> 18 years old) - Renewal Therapy (Required annually to check for therapy benefit)

AIDS Wasting – New Therapy

1. Is the diagnosis AIDS wasting as defined by CDC? Yes: Go to #2. No: Pass to RPH; Deny, (Medical Appropriateness)

2. Is this a request for initiation of growth hormone Yes: Go to #3. No: Go to renewal treatment? criteria

3. Has there been involuntary weight loss > 10% of pre- Yes: Document weights, go No: Pass to RPH. Deny, illness weight with one of the following? #4. (Medical • Chronic diarrhea (at least two loose stools per Appropriateness) day for 30 days or more)? OR • Chronic weakness and documented fever for 30 days in the absence of any condition other than HIV infection that could explain the findings?

4. Is there documentation of failure with other wasting Yes: Document and approve No: Pass to RPH, Deny, treatment modalities (e.g. Nutritional supplementation, for 3 months (AIDS Wasting (Medical dronabinol, megesterol or testosterone)? Appropriateness) Treatment failure is indicated by a lack of overall weight gain of at least 5% in lean body mass in a 6-month treatment duration.

AIDS Wasting– Renewal Therapy

Has client gained or maintained weight? Yes: Document weight No: Pass to RPH; Deny, and approve for 3 (Medical Appropriateness) months(AIDS Wasting

DUR Board Action: 9-18-08ca, 2-23-06, 11-18-03, 9-9-03, Revision(s) 4-15-09, 10-1-03, 9/1/06 Initiated: 10-1-03

Hormones - Leuprolide

Approve for above-the-line conditions, such as central precocious puberty, endometriosis or prostate cancer and medically appropriate short-stature treatment.

Initiative: MAP: Leuprolide

Authorize through age 12 years in girls, age 13 years in boys.

Requires PA: Leuprolide in children and adolescents ages 10 through 18.

GCN Generic Drug Name Label Name Desc 44964 Leuprolide acetate intramusc 22.5mg disp syrin Lupron depot 22.5 mg 3mo kit 44967 Leuprolide acetate sub-q 1mg/0.2ml kit Lupron 2-wk 1 mg/0.2 ml kit 44968 Leuprolide acetate intramusc 30mg kit Lupron depot-4 month kit 44969 Leuprolide acetate sub-q 1mg/0.2ml vial Lupron 1 mg/0.2 ml vial 44970 Leuprolide acetate intramusc 7.5mg disp syrin Lupron depot 7.5 mg kit 44980 Leuprolide acetate intramusc 11.25mg kit Lupron depot 11.25 mg 3mo kt 45017 Leuprolide acetate intramusc 3.75mg kit Lupron depot 3.75 mg kit 47665 Leuprolide acetate intramusc 11.25mg kit Lupron depot-ped 11.25 mg kt 47666 Leuprolide acetate intramusc 7.5mg kit Lupron depot-ped 7.5 mg kit 47851 Leuprolide acetate intramusc 15mg kit Lupron depot-ped 15 mg kit 50363 Leuprolide acetate sub-q 7.5mg disp syrin Eligard 7.5 mg syringe 50857 Leuprolide acetate sub-q 22.5mg disp syrin Eligard 22.5 mg syringe 51826 Leuprolide acetate sub-q 30mg disp syrin Eligard 30 mg syringe 58789 Leuprolide acetate sub-q 45mg disp syrin Eligard 45 mg syringe

Approval Criteria

1. What is the diagnosis being treated with leuprolide; what Record diagnosis and ICD9 code being is the age and gender of the patient? treated.

Yes, Go to #3. No: Pass to RPH; 2. Is the patient female & < 13 years old or Go to #3 male & < 14 years old?

3. Is the diagnosis one of the following? Yes: Approve No: Pass to RPH; -central precocious puberty (CPP) aka precocious sexual through: Go to #4 development & puberty NOC ICD-9 259.1; -endometriosis ICD-9 617.0-617.9; ¾ Age 12 for -prostate cancer ICD-9 185, 189, 198; female -uterine fibroids 218.9 ¾ Age 13 for male • Note that CPP is often associated with hydrocephalus, cranial irradiation, Silver-Russell syndrome, hypothalamic tumor, or hamartoma. • All above diagnosis & conditions are rare in children and adolescents.

4. RPH only

All other indications need to be evaluated as to whether they are above the line or below the line.

• If above: Deny, (Medical Appropriateness), e.g. when initial treatment not until age 10 years in girls, or age 12 years in boys; CPP beyond age 12 years in girls, or age 13 years in boys. Refer unique situations to Medical Director of DMAP. • If below: Deny, (Not Covered by the OHP), e.g unspecified psychosexual disorder, as sexual deviancy, or chemical castration as sexual disorder NOS, ICD-9 302.9

DUR Board Action: 9/20/07(reh) Revision(s): Initiated: Via Retro DUR 11/07, 7/1/09 via PA 54

Hormones - Testosterone

Goal(s):

¾ Cover only for covered diagnosis and for medically appropriate conditions.

¾ Use for body building is not covered.

¾ Use for sexual dysfunction is not covered.

Length of Authorization: 6 months

Covered Alternatives: Oral and IM testosterone DO NOT require PA.

Requires PA: HIC3 = F1A and ROA = TRANSDERM

Drug Code Brand Name Generic Name

GCN = 021606 & 021607 Testoderm patch Testosterone patch

GCN = 045215 & 045216 Androgel, Testim Testosterone gel

GCN = 024137, 031376, 057874 Androderm, Testosterone patch Testoderm TTS

GCN=045972, 051614 First-Testosterone Testosterone Cream or Ointment

GCN = 029239 DHEA Prasterone w/ Vitamin E cream

Approval Criteria

1. What is the diagnosis being treated with topical Record the ICD9 code being treated with topical testosterone? testosterone.

2. Does the diagnosis for the medication requested Yes: Approve medication No: Pass to RPH include any of the following? x 6 mos (use appropriate RPH go to #3. PA reason) • Ovarian failure (256.31, 256.39) • Testicular Hypofunction (257.2) • Hypopituitarism and related disorders (253.2, 253.4, 253.7, 253.8) • AIDS-related cachexia (253.2)

3. RPH only Above: Deny, Below: Deny,

(Medical (Not Covered by the All other indications need to be evaluated to see if they Appropriateness) OHP) are above the line or below the line.

DUR Board Action: 2-23-06, 2-21-01, 9-6-00 Revision(s): 9/1/06 55

Laxatives (Selected Laxitives)

Length of Authorization: 4 weeks to 12 months

Not covered by OHP: Disorders of function of stomach and other functional digestive disorders (ICD-9: 536.0-536.3, 536.8-536.9, 537.1-537.2, 537.5-537.6, 537.89, 537.9, 564.0-564.7, 564.9). This includes chronic constipation and Irritable Bowel Syndrome.

Covered Alternatives (do not require prior authorization): lactulose, senna, sorbitol, polyethylene glycol (PEG, Miralax, Glycolax) and all other FDA approved laxatives.

Requires PA: GCN Brand Generic 060341, 063946 Amitiza Lubiprostone 064008, 064011 Relistor Methylnaltrexone Bromide

Approval Criteria

1. What is the diagnosis and ICD9 code being treated? Record the ICD9 code.

2. Is request for methylnaltrexone (Relistor)? Yes: Go to #3. No: Go to #4.

3. Does the patient average < 3 spontaneous bms per week for at Yes: Go to #8. No: Pass to RPH; Deny, least 4 weeks AND have life expectancy less than 6 months AND Medical Appropriateness continuous opioids for > 60 days? (only approvable for late- stage, advanced illness in a chronic condition or cancer, receiving continuous opioids)

4. Is the diagnosis IBS (564.1)? Yes: Pass to No: Go to #5. RPH, Deny Not Covered by the OHP.

5. Is the diagnosis constipation (564.0, 564.2-564.7, 564.9) or Yes: Go to #6. No: Pass to RP Go to #9. gastroparesis (536.3)?

6. Is the constipation or gastroparesis secondary to one of the Yes: Go to #7. No: Pass to RPH Go to #9. following?: 9 Cancer (140-239) 9 Diabetes (250) 9 Neurologic disorders (330-337)

7. Is patient >18 years old? Yes: Go to #8. No: Pass to RPH; Deny, Medical Appropriateness

8. Has patient failed, or become intolerant to, an adequate trial (2 Yes: Approve for No: Pass to RPH. Go to #9. weeks) of at least 3 of the following categories? 4 months. Continued A Dietary modification—increased dietary fiber (25 coverage will be g/day) dependent on B Fiber supplementation/bulk laxatives (Psyllium, documentation to Metamucil,Perdiem, Fibercon, etc) support clinical C Saline laxatives (milk of magnesia, magnesium response and citrate, Fleet phospho-soda, etc) lack of adverse D Stimulant laxative (senna, bisacodyl, cascara effects to therapy. sagrada, etc) E Lactulose, sorbitol or polyethylene glycol (Miralax,

Glycolax, etc)

9. RPH only ¾ All other indications need to be evaluated to see if they are above or below the line.

¾ Lubiprostone (Amitiza): IBS not approvable. Chronic constipation secondary to an above the line diagnosis not listed above is approvable if medically appropriate and #7 & #8 are met.

¾ Methylnaltrexone (Relistor) is only approvable for late-stage, advanced illness in a chronic condition or cancer, receiving continuous opioids. Use beyond 4 months has not been studied. No efficacy or safety RCT's beyond 2 weeks have been done to date.

DUR Board Action: 12/4/08klk, 3/19/09 Revision(s): Initiated: 7/1/09

Leukotriene Inhibitors

Goal(s):

¾ Approve montelukast only for covered diagnosis.

¾ Allergic rhinitis treatment is covered by the OHP only when complicated by other diagnoses (e.g. Asthma, sleep apnea).

¾ Promote use that is consistent with Oregon Asthma Guidelines and medical evidence. Http://www.oregon.gov/DHS/ph/asthma/pubs.shtml#oregon

Length of Authorization: 6 months or 2 years, (diagnosis specific)

Covered Alternatives:

Allergic Rhinitis: certirizine, chlorpheniramine, diphenhydramine, loratidine & hydroxyzine DO NOT require prior authorization.

Asthma: oral corticosteroid inhalers (see preferred drug list options at http://www.oregon.gov/DHS/healthplan/tools_prov/pdl.shtml), long-acting beta-agonist inhalers and zarfirlukast (Accolate) DO NOT require prior authorization.

Requires PA: Singulair (montelukast) HSN= 016911

Approval Criteria

1. What is the diagnosis being treated? Record the ICD9 code.

2. Does client have asthma or reactive airway Yes: Approve for 2 years No: Go to #3. disease (ICD-9: 493.xx)?

3. Does client have diagnosis allergic rhinitis, Yes: Go to #4. No: Go to #6. allergic conjunctivitis, or chronic rhinitis/pharyngitis/nasophrynigitis? (ICD-9: 472.xx, 372.01-05, 372.14, 372.54, 372.56, 477.xx, 995.3, V07.1

4. Does client have other co-morbid conditions Yes: Go to #5. or complications that are above the line? No: PASS to RPH;

• Acute or chronic inflammation of the orbit Deny, (376.0 – 376.12) (Not Covered by the OHP). • Chronic Sinusitis (473.xx) • Acute Sinusitis (461.xx) • Sleep apnea (327.20,327.21,327.23- 327.29,780.51, 780.53, 780.57) • Wegener’s Granulomatosis (ICD-446.4)

5. Does client have contraindications (e.g. Yes: Approve 6 months No: Pass to RPH; Deny, (Cost- Pregnant) or had insufficient response to at Effectiveness) least 2 available alternatives? Document.

6. Is the diagnosis COPD(496) or Obstructive Yes: Pass to RPH; Deny, No: Pass to RPH; Go to #7. Chronic Bronchitis? (491.1-491.2) (Medical Appropriateness). Leukotriene not indicated

7. Is the diagnosis Chronic Bronchitis? (491.0, Yes: Pass to RPH; 491.8, 491.9) Deny, (Not Covered by the No: Pass to RPH Go to #8. OHP) MESSAGE:“The treatment for your condition is not a covered service on the Oregon Health Plan.”

8. RPH only: Is the diagnosis above the line or Above: Deny with Below: Deny, (Not Covered by below the line? yesterday’s date (Medically the OHP) “The treatment for Appropriateness) your condition is not a covered service on the Oregon Health Use clinical judgment to Plan.” APPROVE for 1 month starting today to allow time (e.g. URI-465.9 or Uticaria- for appeal. 708.0,708.1,708.5,708.8,995.7, should be denied) MESSAGE: ”Although the request has been denied for long term use because it is considered medically inappropriate, it has also been APPROVED for one month to allow time for appeal.”

Refer questions regarding coverage to DMAP.

DUR Board Action: 9-18-08reh, 2-23-06, 9-14-04, 5-25-04 Revision(s): 7-1-09, 9-1-6, 7-1-06, 5-31-05, 4-1-05 Re-established, Suspended 12-17-04 Initiated: 11-18-04

59 Lyrica (Pregabalin)

Goal(s):

¾ Cover pregabalin only for above-the-line diagnoses that are supported by the medical literature (e.g. Epilepsy, diabetic neuropathy, post-herpetic neuralgia).

¾ Pregabalin has not demonstrated superiority to other first-line treatments for neuropathic pain and its use should be reserved for treatment failure.

Length of Authorization: 90 days to Lifetime (criteria specific)

Covered Alternatives: Anxiety: SSRIs, TCAs, Benodiazepines, Buspirone Neuropathic pain: TCAs, Tramadol, Carbamazepine.Gabapentin

Requires PA: Pregabalin (Lyrica) HSN=026470

Approval Criteria

1. What is the diagnosis being treated? Record the ICD9 code.

Does client have diagnosis of epilepsy? 2. Yes: Approve for lifetime (until 12-31- No: Go to #3. (ICD-9 code 345.0-345.9, 780.39, or 907.0) 2036)

Does the client have rheumatism, 3. Yes: Pass to RPH; Go to #7 No: Go to #4. unspecified or fibrositis, fibromyalgia/ myalgia or myositis or below the line neuralgia/neuritis? (729.0, 729.1 or 729.2)

Does client have diagnosis of one the 4. Yes: Go to #5. No: Go to #6. following? • Diabetic neuropathy (ICD9: 250.6 & subsets) – Document diabetic therapy (supporting meds) • Post-herpetic neuralgia (ICD9: 053 & subsets) • Trigeminal and other above the line neuralgias (ICD9 350, 352)

5. Has the client tried or are they Yes: Approve for 90 days with No: Pass to RPH; Deny, contraindicated to gabapentin AND one of the subsequent approvals dependent on (Medical following? documented* positive response for Appropriateness) and • Tcas lifetime (12-31-2036) recommend trial of • Carbamazepine *Documented response means that covered alternative. follow-up and response is noted in client’s Document drugs tried or contraindications. chart per clinic staff

6. Does the client have an anxiety disorder Yes: Go to #7. No: Go to #8. (ICD9 300xx)

7. Has the client tried or are they Yes: Approve for 90 days with No: Pass to RPH; Deny, contraindicated to at least two of the following subsequent approvals dependent on (Medical drug classes? documented* positive response for Appropriateness) and • Ssris lifetime (12-31-2036) approval. recommend trial of • Tcas covered alternative. • Benzodiazepines • Buspirone

Document drugs tried.

8. Pass to RPH • For Bipolar affective disorder: there is no data to support its use for this indication,(Deny Medical Appropriateness) recommend other alternatives (lithium, valproate, carbamazepine, lamotrigine)

• For Migraine prophylaxis: there is no data to support its use for this indication,(Deny Medical Appropriateness) recommend other alternatives (beta-blockers, calcium channel blockers, valproate, gabapentin, tcas) Refer to American Academy of Neurology Guideline http://www.neurology.org/cgi/reprint/55/6/754.pdf

• If clinically warranted, may DENY yesterdays date (Medical Appropriateness) and use clinical judgement to APPROVE for 1 month starting today to allow time for appeal.

• MESSAGE:”Although the request has been denied for long term use because it is considered medically inappropriate, it has also been APPROVED for one month to allow time for appeal.”

All other indications need to be evaluated to see if diagnosis is above or below the line: o Above the line neuropathies found in table 1 (list is not all inclusive) may be approved for 90 days with subsequent approvals dependent on documented positive response.( Documented response means that follow- up and response is noted in client’s chart per clinic staff) ALSO see footnote**

o Below the line neuropathies such as those found in table 2 (list is not all inclusive) that are related to above the line diagnoses found in table 3 may be approved for 90 days with subsequent approvals dependent on documented positive response.( Documented response means that follow-up and response is noted in client’s chart per clinic staff) ALSO see footnote**

Below the line diagnoses should be DENIED (Not covered by the OHP)

** Please forward any neuropathy/neuralgia ICD-9 codes not found in the Table 1 to the Lead Pharmacist. These codes will be forwarded to DMAP for consideration.

Table 1 – Examples of other above the line neuropathies. ICD-9 Description 337.0 Idiopathic Peripheral autonomic neuropathy 354.2 Ulner nerve lesion 356 – 356.9 Hereditary and idiopathic peripheral autonomic neuropathy 357.89, 357.9 Inflamatory Polyneuropathy 723.4 Brachial neuritis or radiculitis 724.4 Thoracic or Lumbosacral neuritis or radiculitis unspecified Table 2 – Examples of below the line diagnosis that can be approved ONLY If due to a condition that is found in Table 3 ICD-9 Description 337.2 Reflex sympathetic dystrophy 337.3 Autonomic Dysreflection 724.3 Sciatia –Neuralgia or neuritis of sciatic nerve 729.1 Myalgia Myositis 729.2 Neuralgia/Neuritis and Radiculitis Unspecified Table 3 – Above line condition that can be the basis of below line neuropathy found in Table 2. ICD-9 Above the line Condition 336.9 Unspecified disease of spinal cord 340 Multiple sclerosis 344.0 Quadraplegia 344.1 Paraplegia 754.2 Scoleosis 737.3 Kyphoscolosis 907.0 Late effects of injuries to nervous system

DUR Board Action:(9-20-2007, 11-29-2007) Revision(s): Initiated: 4/1/08 61 Marinol (Dronabinol) Goal:

Cover drugs only when used for covered OHP diagnoses, and restrict use to instances where medical evidence supports use (e.g. Nausea associated with chemotherapy).There is limited medical evidence supporting the use of dronabinol for many conditions. Http://pharmacy.oregonstate.edu/drug_policy/pages/dur_board/reviews/articles/dronabinol.html

Length of Authorization: 6 months to lifetime (criteria specific)

Covered Alternatives: Metoclopramide (Reglan), Prochlorperazine (Compazine) Promethazine (Phenergan) 5 HT3 antagonists (Zofran, Anzemet, or Kytril) – PA’D for >3 days.

Requires PA: HSN = 001955 dronabinol (MARINOL) No quantity limits for Oncology (cancer) related antiemetic use.

Quantity Limits: 2.5mg & 5mg - - 3 units / day 10mg- - - 2 units / day Apply only to AIDS/HIV related anorexia and Non-Oncology related antiemetic use

Approval Criteria

1. What is the diagnosis being treated? Record the ICD9 code being treated.

2. Does client have diagnosis of anorexia Yes: Approve for lifetime (until 12-31-2036)Apply No: Go to #3. associated with AIDS? HIV? quantity limit (Anorexia associated with AIDS/HIV)

3. Does client have current diagnosis of Yes: Approve for length of chemo or radiation No: Go to #4. cancer AND receiving chemotherapy or therapy. radiation therapy? No quantity limit. (Chemotherapy or Radiation, whichever is applicable)

4. Does client have refractory nausea that Yes: Go to #5. No: Go to #7. would require hospitalization or ER visits?

5. Has client tried two medications listed Yes: Approve for up to six months. Apply quantity No: Go to #6. below? limit (Refractory Nausea With Failure of Alternative

Meds) Generic Name Brand Name

Metoclopramide Reglan Prochlorperazine Compazine Promethazine Phenergan

5 HT3 drugs - Anzemet, Kytri, or Zofran

6. Does client have contraindications, such as Yes: Approve for up to six months. Apply quantity No: Go to #7. allergies, or other reasons they CANNOT use limit (Refractory Nausea With Contraindication of these anti-emetics? Document reason. Alternative Meds)

7. Does client have ONE of more of following No: Pass to Yes: Pass to RPH; Deny, diagnosis? Cancer associated anorexia, RPH; Go to (Medical Appropriateness) dystonic disorders, glaucoma, migraine, #8. multiple sclerosis, pain

8. RPH only Below: Deny, Above: Deny, (Medical Appropriateness) All other indications need to be evaluated to (Not-Covered see if they are above or below the line by the OHP)

DUR Board Action: 2-23-06,2-24-04, 2-11-03 Revision(s): 7-1-06, 5-31-05 Effective: 4-1-03 62

Milnacipran (Savella)

Goal(s):

Cover milnacipran only for above-the-line diagnoses that are supported by the medical literature (e.g., depression).

Initiative: Map: milnacipran (Savella)

Length of Authorization: 1 year

Covered Alternatives: SSRIs, TCAs, other antidepressents

Requires PA: milnacipran (Savella) HICL Seq Number = 21229

Approval Criteria

1. What is the diagnosis? Record ICD9 code and reject/internal error code.

2. Does the client have rheumatism, unspecified or Yes: Pass to RPH; Deny, No: Go to #2. fibrositis, fibromyalgia/myalgia or myositis or below-the- (Not covered by the OHP) line neuralgia/neuritis (728.0, 729.1 or 729.2)?

3. Does the client have an anxiety disorder or Yes: Approve for one year. No: Go to #3. depressive disorder (ICD9 296xx, 300xx, 309xx,

311xx)?

4. Pass to RPH

All other indications need to be evaluated to see if diagnosis is supported by the medical literature and above or below the OHP coverage line.

For Psychiatric Disorders other than Depression: There is no data to support its use for any psychiatric indication other than depression indication, (Deny Medical Appropriateness) recommend other alternatives as appropriate. Evidence for use as an antidepressant is from European trials.

Below the line diagnoses should be Denied (not covered by the OHP).

DUR Board Action: 5/21/09 Revisions: Iniatited: 1/1/10

Nasal Inhalers

Goal(s):

¾ Approve use of nasal inhalers only for covered diagnosis. ¾ Allergic rhinitis treatment is covered by the OHP only when complicated by other diagnoses (e.g. asthma, sleep apnea). ¾ Promote use that is consistent with Oregon Asthma Guidelines and medical evidence. http://www.oregon.gov/DHS/ph/asthma/pubs.shtml#oregon

Length of Authorization: 6 months

Covered Alternatives: Oral corticosteroid inhalers, certirizine, chlorpheniramine, diphenhydramine, loratidine & hydroxyzine DO NOT require prior authorization.

Requires PA: Nasal antihistamines, Nasal cromolyn, Nasal steroids

(LIST MAY NOT BE INCLUSIVE OF ALL DRUGS)

HIC3 Code Generic Name Brand Name(s) Q7E azelastine Astelin Q7H cromolyn NasalCrom

Q7P beclomethasone Beconase AQ, Vancenase

budesonide Rhinocort flunisolide Nasarel, Nasalide fluticasone Flonase mometasone Nasonex triamcinolone Nasacort AQ, Tri-Nasal

ciclesonide Omnaris

Approval Criteria

1. What is the diagnosis being Record the ICD9 code being treated. treated?

2. Does patient have diagnosis Yes: Go to #3. No: Go to #7. allergic rhinitis, allergic conjunctivitis, or chronic rhinitis/pharyngitis/nasophrynigitis? (ICD-9: 472.xx, 372.01-05, 372.14, 372.54, 372.56, 477.xx, 995.3, V07.1

3. Does patient also have asthma or Yes: Go to #4. No: Go to #5. reactive airway disease exacerbated by chronic/allergic rhinitis (493.xx)?

4. Does the drug profile show an Yes: Approve for 6 months If No: Pass to RPH; Deny, (Medical asthma controller medication (e.g. Appropriateness ORAL inhaled steroid, leukotriene Oregon Asthma guidelines antagonist, etc.) &/or rescue beta- recommend all asthma patients have agonist (e.g. albuterol) within the last 6 access to rescue inhalers and those months? with persistent disease should use (Keep in mind albuterol may not anti-inflammatory medicines daily need to be used as often if asthma (preferably orally inhaled steroids). is controlled on other medications.)

5. Does patient have other co-morbid Yes: Document ICD-9 codes and go to No: If No, Pass to RPH; conditions or complications that are #6. Deny, (Not Covered by the OHP). above the line?

• Acute or chronic inflammation of the orbit (376.0 – 376.12) • Chronic Sinusitis (473.xx) • Acute Sinusitis (461.xx) • Sleep apnea (327.20,327.21,327.23- 327.29,780.51, 780.53, 780.57)

Wegener’s Granulomatosis (ICD- 446.4)

6. Does patient have contraindications Yes: Approve 6 months. No. Pass to RPH; Deny, (Cost- (e.g. pregnant), or had insufficient Effectiveness) response to available alternatives ? Document:

7. Is the diagnosis COPD(496) or Yes: Pass to RPH; No: Pass to RPH; Go to #8. Obstructive Chronic Bronchitis (491.1- Deny, (Medical Appropriateness). 491.2) Nasal steroid not indicated

8. Is the diagnosis Chronic Bronchitis Yes: Pass to RPH; No: Pass to RPH; Go to #9. (491.0, 491.8, 491.9)? Deny, (Not Covered by the OHP)

9. RPH only: Is the diagnosis above Above: Deny, yesterday’s date Below: Deny, (Not Covered by the the line or below the line? (Medically Appropriateness) OHP) (e.g. URI-465.9 or Uticaria- 708.0,708.1,708.5,708.8,995.7, should be denied)

Refer questions regarding coverage to DMAP.

DUR Board Action: 9-18-08reh, 2-23-06, 9-14-04, 5-25-04, 2-10-02, 5-7-02 Last Revision(s): 8-11-09,7-1-09, 9-1-06, 7-1-06, 3-20-06, 5-31-05, 10-14-04, 8-1-02, Initiation: ??

Nutritional Supplements (Oral Administration Only)

¾ Restrict use to clients unable to take food orally in sufficient quantity to maintain adequate weight. ¾ Requires ANNUAL nutritional assessment for continued use. ¾ Use restriction consistent with DMAP EP/IV rules at: http://www.dhs.state.or.us/policy/healthplan/guides/homeiv/main.html

These products are NOT Federally rebate-able; Oregon waives the rebate requirement for this class.

PLEASE NOTE: 9 Nutritional formulas, when administered enterally ( g-tube), are no longer available through the point of sale system. 9 Service providers should use the CMS 1500 form and mail to DMAP, P.O. Box 14955, Salem, Oregon, 97309 or the 837P electronic claim form, and not bill through POS. 9 When billed correctly with HCPCS codes for enterally given supplements, enterally administered nutritional formulas do not require a prior authorization. However, the equipment does require a PA (i.e., pump). 9 Providers can be referred to 800-642-8635 or 503-945-6821 for enteral equipment PAs 9 For complete information on how to file a claim, go to: Http://www.dhs.state.or.us/policy/healthplan/guides/homeiv/main.html

Length of Authorization: up to 1 year

Note: Criteria divided into: 1) Clients 6 years or older 2) Clients under 6 years

For Nutritional Supplement Fax Questionnaire, see Appendix

Not-Covered: Supplements and herbal remedies such as Acidophilis, Chlorophyll, Coenzyme Q-10, Fish Oil, are not covered and should not be approved.

Requires PA: All supplemental nutrition products in HIC3 = C5C, C5F, C5G, C5U, C5B (Nutritional bars, liquids, packets, powders, wafers such as Ensure, Ensure Plus, Nepro, Pediasure, Promod).

CLIENTS 6 YEARS OR OLDER

Document:

• Name of product being requested • Physician name • Quantity/Length of therapy being requested

Approval Criteria

1. What is the diagnosis responsible for needing Record ICD9 code being treated. nutritional support?

2. Is product requested a supplement or herbal Yes: Pass to RPH; Deny, No: Go to #3. product without an FDA indication? (Medical Appropriateness )

3. Is the product to be administered by enteral Yes: Go to #10. No: Go to #4. tube feeding ( g-tube)?

4. All indications need to be evaluated as to Above the line: Below the line: Pass to RPH; whether they are above the line or below the line: Go to #5. Deny, (Not Covered by the OHP).

5. Is this request for a client that is currently on Yes: Go to #6. No: Go to #7. supplemental nutrition?

6. Has there been an annual assessment by MD Yes: Approve up to 1 year No: Request documentation of for continued use of nutritional supplement? assessment OR Pass to RPH; Document assessment date Deny, (Medical Appropriateness)

7.Client must have a nutritional deficiency Yes: Approve for up to 1 year No: Go to #8. identified by one of the following: • Has there been a recent (within year) Registered Dietician assessment indicating adequate intake is not obtainable through regular/liquefied or pureed foods? (Supplement cannot be approved for convenience of client or caregiver.) OR • Is there a recent serum protein level < 6?

8. Does the client have a prolonged history (>1 Yes: Go to #9. No: Request more documentation year) of malnutrition and cachexia OR reside in a OR Pass to RPH; Deny, (Medical LTC facility or chronic home care facility? Appropriateness) Document: • Residence • Current weight • Normal weight

9. Does the client have: Yes: Approve for up to 1 year No: Request more documentation • An increased metabolic need resulting OR Pass to RPH; Deny, (Medical from severe trauma (e.g. Severe burn, Appropriateness) major bone fracture, etc.)? OR • Malabsorption difficulties (e.g. Crohns Disease, Cystic Fibrosis, bowel resection/ removal, Short Gut Syndrome, gastric bypass, renal dialysis, dysphagia, achalasia, etc)? OR • A diagnosis that requires additional calories and/or protein intake (e.g. Cancer, AIDS, pulmonary insufficiency, MS, ALS, Parkinson’s, Cerebral Palsy, Alzheimers, etc.)

10. Is this request for a client that is currently on Yes: Approve for 1 month No: Enter an Informational PA and supplemental nutrition? and reply: reply: Nutritional formulas, when Nutritional formulas, when administered by enteral tube, are administered by enteral tube, no longer available through the are no longer available point of sale system. For future use, through the point of sale service providers should use the system. For future use, CMS form 1500 or the 837P service providers should use electronic claim form and not bill the CMS form 1500 or the through POS. When billed using a 837P electronic claim form HCPCS code, enterally and not bill through POS. A administered nutritional formulas do one-month approval has been not require a prior authorization. given to accommodate the However, the equipment does transition. require a PA. Providers can be referred to 800-642-8635 or 503- Please visit: 945-6821 for enteral equipment http://www.dhs.state.or.us/pol pas. icy/healthplan/guides/homeiv/ main.html For complete information of how to file a claim, please visit: Http://www.dhs.state.or.us/policy/he althplan/guides/homeiv/main.html

CLIENTS AGED 5 YEARS and UNDER

Document:

• Name of product being requested • Physician name • Quantity/Length of therapy being requested

Approval Criteria

1. What is the diagnosis being treated that is Record the ICD9 codes. responsible for needing nutritional support?

2. All indications need to be evaluated as to whether Above the line: Go to Below the line: Pass to RPH; they are above or below the line covered diagnoses. #3. Deny, (Not Covered by the OHP)

3. Is the product to be administered by enteral tube Yes: Go to #9. No: Go to #4. feeding (g-tube)?

4. Is this request for a client that is currently on Yes: Go to #5. No: Go to #6. supplemental nutrition?

5. Has there been an annual assessment by MD for Yes: Approve up to 1 No: Request more documentation continued use of nutritional supplement? No recent year OR Pass to RPH; Deny, (Medical weight loss, serum protein level or dietitian Appropriateness) assessment required if body weight being maintained by supplements due to clients medical condition). Document assessment date.

6. Is the diagnosis failure to thrive (FTT)? (783.41) Yes: Approve for up to 1 No: Go to #7. year.

7. Does the client have: Yes: Approve for up to 1 No: Go to #8. • An increased metabolic need resulting from year. severe trauma (e.g. Severe burn, major bone fracture, etc.)? OR • Malabsorption difficulties (e.g. Crohns Disease, Cystic Fibrosis, bowel resection/ removal, Short Gut Syndrome, gastric bypass, renal dialysis, dysphagia, achalasia, etc)? . OR • A diagnosis that would require additional calories and/or protein intake (e.g. Cancer, AIDS, pulmonary insufficiency, Cerebral Palsy, etc.)

8. Client must have a nutritional deficiency identified Yes: Approve for up to 1 No: Request more documentation by one of the following: year. OR Pass to RPH; Deny, (Medical • Has there been a recent (within year) Appropriateness)) Registered Dietician assessment indicating adequate intake is not obtainable through regular/liquefied or pureed foods? (Supplement cannot be approved for convenience of client or caregiver.) OR • Is there a recent serum protein level <6?

9. Is this request for a client that is currently on Yes: Approve for 1 month No: Enter an Informational PA and supplemental nutrition? and reply: reply: Nutritional formulas, when Nutritional formulas, administered by enteral tube, are when administered by no longer available through the enteral tube, are no point of sale system. For future use, longer available through service providers should use the the point of sale system. CMS form 1500 or the 837P For future use, service electronic claim form and not bill providers should use the through POS. When billed using a CMS form 1500 or the HCPCS code, enterally 837P electronic claim administered nutritional formulas do form and not bill through not require a prior authorization. POS. A one-month However, the equipment does approval has been given require a PA. Providers can be to accommodate the referred to 800-642-8635 or 503- transition. 945-6821 for enteral equipment pas. Please visit: http://www.dhs.state.or.us For complete information of how to /policy/healthplan/guides/ file a claim, please visit: homeiv/main.html Http://www.dhs.state.or.us/policy/he althplan/guides/homeiv/main.html

Note: Normal Serum Protein 6 – 8 g/dl Normal albumin range 3.2 – 5.0 g/dl

DUR Board Action: 2-23-06 Revision(s): 9-1-06, 7-1-06, 4-1-03, 6/22/07 Initiated:

Opioids - Long-Acting

Initiative: Long Acting Opioids for PDL

Length of Authorization: Up to 1 year

Approve use of non-preferred long-acting opioids only for covered diagnosis.

OHP does not cover:

Includes ICD9: Includes ICD9:

Disorders of soft Acute and chronic 721.0 729.0-729.2, tissue disorders of spine 721.2-721.3 729.31-729.39, OR without neurologic 721.7-721.8 729.4-729.9, impairment 721.90 V53.02 722.0-722.6

722.8-722.9 723.1 723.5-723.9 724.1-724.2 724.5-724.9 739 839.2 847

Preferred Alternatives: Listed at: http://www.oregon.gov/DHS/healthplan/tools_prov/pdl.shtml

Requires PA: GCN Brand Generic

050219 050222 Avinza Morphine Sulfate 050221 050220

065544 065545 065546 Embeda Morphine Sulfate/ Naltrexone 065547 065548

065549

015883 059102 015880 Duragesic & Generics Fentanyl 015881 015882

061092 063783 061093 Opana ER Oxymorphone HCL 063784 061094 061091 063782

024504 063515 Oxycontin & Generics Oxycodone HCL 045129 024505 063516 024506 063517 025702 70

Approval Criteria

1. What is the patient’s diagnosis? Record ICD9 code.

2. Will the prescriber consider a change to a Yes: Inform provider of covered No: Go to #3. preferred product? alternatives in class. Message: http://www.dhs.state.or.us/policy/healt • Preferred products do not require PA. hplan/guides/pharmacy/main.html • Preferred products are evidence-based reviewed for comparative effectiveness & safety by the Health Resources Commission (HRC).

Reports are available at: http://www.oregon.gov/OHPPR/HRC/Evidence_ Based_Reports.shtml.

3. Is the diagnosis above the line Yes: Go to #8. No: Go to #4. (see above for examples of diagnoses not covered)?

4. Is the diagnosis chronic back pain Yes: Pass to RPH, Go to #5. No: Go to #6.

721.0 723.1 721.2-721.3 723.5-723.9 721.7-721.8 724.1-724.2 721.90 724.5-724.9 722.0-722.6 739 722.8-722.9 839.2

847

5. Is there neurologic impairment defined as Yes: Document objective evidence with No: Go to #6. objective evidence of at least 1 of the following: chart notes; Go to #10.

a. Reflex loss b. Dermatomal muscle weakness c. Dermatomal sensory loss d. EMG or NCV evidence of nerve root impingement e. Cauda equina syndrome f. Neurogenic bowel or bladder

6. Is this new therapy (i.e. no previous Yes: Pass to RPH, No: Go to #7. prescription for the same drug last month)? Deny; (Not Covered by the OHP)

7. Is this patient terminal (< 6 months) or Yes: Approve for 6 months. No: Go to #8. admitted to hospice?

8. Does dose exceed 120mg Morphine Yes: Go to #9. No: Go to #10. Equivalents per day?

a. Fentanyl 50mcg/day b. Hydromorphone 30mg/day c. Oxycodone 80mg/day d. Oxymorphone 40mg/day e. Methadone 40mg/day

9. Is the patient seeing a single prescribing Yes: Approve for 90 days. Refer to Rx No: Approve 30 days practice & pharmacy for pain treatment? “Lock-in” program for evaluation, only; Refer to Rx Lock- monitoring & potential taper. In program for evaluation, monitoring Further approvals pending & potential taper. RetroDUR/Medical Director review of case. Further approvals pending RetroDUR/Medical Director review of case.

10. Is the patient concurrently on other long- Yes: Pass to RPH. Go to #11. No: Approve for up to 1 acting opioids (e.g. fentanyl patches, year. methadone, or long-acting morphine, long- acting oxycodone, long-acting oxymorphone)?

11. Is the duplication due to tapering or Yes: Approve for 30-90 days at which No: Deny, switching products? time duplication LAO therapy will no Appropriateness. longer be approved. The concurrent use of multiple long-acting May approve for taper narcotics is not recommended unless tapering only. and switching products. Consider a higher daily If necessary, inform dose of a single long-acting opioid combined prescriber of provider with an immediate release product for reconsideration process breakthrough pain. and refer to RetroDUR http://www.ohsu.edu/ahec/pain/home.html for review.

DUR Board Action: 12/3/09 (KS), 9/9/09(klk),12/4/08klk, 3/19/09 Revision(s): 1/1/10 Initiated: 7/1/09

Opioids - Methadone – High Dose Limit

Goal(s):

¾ Ensure safe use of methadone. ¾ Approval for >100mg/day only after assessment of QTc risk factors by prescriber. ¾ Methadone has been associated with adverse cardiac effects as stated below in an excerpt of the FDA Black Box Warning:

Cases of QT interval prolongation and serious arrhythmia (torsades de pointes) have been observed during treatment with methadone. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction.

See Oregon DUR Board newsletter at: http://pharmacy.oregonstate.edu/drug_policy/pages/dur_board/newsletter/articles/volume11/DURV11I2.pdf http://pharmacy.oregonstate.edu/drug_policy/pages/dur_board/newsletter/articles/volume5/5_5.html

Initiative: Methadone High Dose Limit Length of Authorization: up to 6 months

Preferred Alternatives: Listed at: http://www.oregon.gov/DHS/healthplan/tools_prov/pdl.shtml

Approval Criteria

1. Does the patient have any of the following QTc Yes: Go to #2. No: Approve up to 6 Risk Factors? months but be sure prescriber is aware of a) Family history of “long QTc syndrome”, black box warning. syncope, sudden death b) Potassium depletion primary or secondary to drug use ( i.e. diuretics) c) Concurrent use of C34 inhibitors or QTc prolonging drugs (see table below) d) Structural heart disease, arrhythmias, syncope

2. Is this new therapy (i.e. no previous Yes: Pass to RPH; Deny, (Medical No: Pass to RPH, prescription for the same drug last month)? Appropriateness) Approve for 30-60 days to Go over black box warning and allow time to taper or offer alternatives (e.g. Duragesic or transition to alternative. LA morphine). Direct to DUR Newsletter for assistance. Refer to Rx “Lock-in” Program for evaluation and monitoring.

Table 2 – Possible Methadone drug interactions causing QTc prolongation or cardiac arrhythmias

Drug / Drug Class CYP 450 QT prolonging Contraindicated Clarithromycin, erythromycin, telithromycin x x Itraconazole, ketoconazole, voriconazole x x Posaconzole x Isoniazide x Quinidine x x HIV reverse transcriptase inhibitors x HIV protease inhibitors x Amiodarone x x Norfloxacin x x Sertraline x Tricyclic antidepressants x Antipsychotics (typical & atypical) x Thioridazine x Ziprasidone x Other antiarrhymics x (see https://online.epocrates.com for complete list) Some fluoroquinolones (spar-, gati-, levo-, moxi-) x Ranolazine x

Source: Epocrates online database. https://online.epocrates.com This is not a comprehensive list of possible drug-drug interactions. Additional drug-drug interactions may be viewed at Epocrates online database (see above url address).

DUR Board Action: 9/24/09(DO/KK), 5//21/09 Revision(s) Initiated: 1/1/10

Opioids - Narcotic Combination – Excessive dose limits

Goal(s):

¾ Avoid adverse effects due to high dose of combined ingredient by enforcing FDA maximum dose labeling.

¾ Pay only for treatment of covered OHP diagnoses

Length of Authorization: None

Covered Alternatives: Pharmacy may need to adjust days supply entry. Prescriber may choose a product with a higher ratio of narcotic to keep APAP or ASA within maximum limits or use a single-ingredient opioid.

Requires PA: Limits by the maximum dose of the non-narcotic ingredient(s). Acetaminophen is not to exceed 4 gms/day. Aspirin is not to exceed 8 gms/day.

Approval Criteria

1. What is the diagnosis being treated with Record ICD9 code being treated with the opioid combination. the opioid combination? (See tables)

2. Does daily dose exceed the maximum Yes: Go to #3. No: Instruct pharmacy to correct days for combination ingredient? supply entry

3. All indications need to be evaluated as Above: Pass to RPH, DENY, Below: Pass to RPH, DENY, (Not to whether they are above the line or below (Medical Appropriateness) Covered by the OHP) the line. Review FDA maximum dose and Review FDA maximum dose and provide alternatives. provide alternatives

Examples of products containing aspirin that are limited 8 grams per day of ASA

Aspirin Combinations

Maximum quantity Maximum quantity Drug Drug per day per day

Codeine /ASA 15/325 mg 24.6 tablets Oxycodone/Oxycodone terp/ASA 24.6 2.25/0.19/325 mg

Codeine/ASA 30/325 mg 24.6 tablets Oxycodone/Oxycodone terp/ASA 24.6 4.5/0.38/325 mg

Codeine/ASA 60/325 mg 24.6 Propoxyphene/ASA 65/325 mg 24.6

Codeine/ASA/Caffeine/Butalbital 24.6 Propoxyphene nap/ASA 100/325 mg 24.6 - 7.5/325/40/50 mg

Codeine/ASA/Caffeine/Butalbital 24.6 Propoxyphene/ASA/Caffeine 32/389/32mg 20.6 - 15/325/40/50 mg

Propoxyphene/ASA/caffeine 65/389/32 mg 20.6

Pentazocine/ASA 22.5/325 mg 24.6

Dihydrocodone/ASA/Caffeine 16.2/356.4/ 22.4

Examples of products containing acetaminophen that are limited to 4 grams per day of APAP

Hydrocodone/APAP combinations

Maximum quantity Maximum quantity Drug Drug per day per day

Hydrocodone/APAP 8 tablets Hydromorphone/APAP10/400 mg 10 tablets 2.5/500mg

Hydrocodone/APAP 5/500mg 8 tablets Hydrocodone/APAP 10/500mg 8 tablets

Hydrocodone /APAP 5/400 10 tablets Hydrocodone/APAP 10/650mg 6.2 tablets mg

Hydrocodone /APAP 7.7/400 10 tablets Hydrocodone/APAP 10/660mg 6.1 tablets mg

Hydrocodone/APAP 8 tablets Hydrocodone 7.5mg/APAP 500mg per 15 ml 120 ml 7.5/500mg Elixir

Hydrocodone/APAP 6.2 tablets Hydrocodone 5 mg/APAP 100mg/5ml 200 ml 7.5/650mg

Hydrocodone/APAP 5.3 tablets Hydrocodone 5 mg/APAP 120 mg/5 ml 166.5 ml 7.5/750mg

Hydrocodone/APAP 12.3 tablets Hydrocodone 2.5 mg/APAP 167 mg/15 ml 359.6 ml 10/325mg

Propoxyphene/APAP combinations

Propoxyphene /APAP 65/650mg 6.1

Propoxyphene nap100mg/APAP 500mg 8

Oxycodone/APAP combinations

Oxycodone/APAP 2.5/325mg 12 tablets

Oxycodone/APAP 5/325mg 12 tablets

Oxycodone/APAP 5/500 8 tablets

Oxycodone/APAP 7.5/325mg 12 tablets

Oxycodone/APAP 7.5/500mg 8 tablets

Oxycodone/APAP 10/325mg 12 tablets

Oxycodone/APAP 10/650mg 6 tablets

Oxycodone/APAP 5/325 per 5 ml 61.5 ml

Codeine/APAP combinations

Codeine/APAP Elixir 120mg/5ml and 12mg/5ml 500 ml

Codeine /APAP 15/300mg (Tylenol #2) 12.3

Codeine /APAP 30/300mg (Tylenol #3) 12.3

Codeine /APAP30/ 300mg (Tylenol #4) 12.3

Tramadol/APAP combinations

Tramadol/APAP 37.5/325mg 12

DUR Board Action: 2-23-06, 11-5-99, 2-10-99 Revision(s) 9-30-05, 5-16-05, 12-1-03, 5-1-03 Initiated:

Preferred Drug List (PDL) – Non-Preferred Drugs in Select PDL Classes

The purpose of this prior authorization policy is to ensure that non-preferred drugs are used for an above-the-line condition.

Select classes include:

Alzheimers Drugs Angiotensin Converting Enzyme Inhibitors Angiotensin Converting Enzyme Inhibitors + Hydrochlorothiazide Angiotensin II Receptor Blockers Angiotensin II Receptor Blockers + Hydrochlorothiazide Beta-Agonists, Inhaled Short-Acting Beta-Blockers, Oral Calcium Channel Blockers, Oral Dihydropyridine Calcium Channel Blockers, Oral Non-Dihydropyridine Diabetes, Oral Hypoglycemics Diabetes, Oral Thiazolidinediones Hormone Replacement Therapy, Oral Hormone Replacement Therapy, Topical Hormone Replacement Therapy, Vaginal Multiple Sclerosis Drugs Overactive Bladder Drugs Platelet Inhibitors Statins & Combinations Targeted Immune Modulators

Initiatives: PDL: Preferred Drug List Length of Authorization: up to 1 year

Preferred Alternatives: All preferreds on PDL list: http://www.oregon.gov/DHS/healthplan/tools_prov/pdl.shtml

Approval Criteria

1. What is the diagnosis? Record ICD9 code.

2. Is this an OHP covered diagnosis? Yes: Go to #3. No: Pass to RPH: Deny, (Not Covered by the OHP).

3. Is this a continuation of current therapy (i.e. Yes: Document prior therapy in No: Go to #4. filled prescription within prior 90 days)? PA record. Approve for 1 year Verify via pharmacy claims. .

4. Will the prescriber consider a change to a Yes: Inform provider of covered No: Approve for 1 year or preferred product? alternatives in class. length of prescription, Message: http://www.dhs.state.or.us/policy whichever is less. • Preferred products do not require PA. /healthplan/guides/pharmacy/mai • Preferred products are evidence-based n.html reviewed for comparative effectiveness & safety by the Health Resources Commission (HRC). Reports are available at: http://www.oregon.gov/OHPPR/HRC/Evidence_B ased_Reports.shtml.

DUR Board Action: 9/24/09(DO), 5/21/09 Revision(s): Initiated: 1/1/10

Pegylated Interferon and Ribavirin

Goal(s): Cover drugs only for those clients where there is medical evidence of effectiveness and safety.

Initiative: Hepatitis C

Length of Authorization: 16 weeks plus 12- 36 additional weeks or 12 months

Requires PA: All drugs in HIC3 = W5G

HSN Brand Generic Form

004184 Copegus Ribavirin Tablet 004184 Rebetol Ribavirin Capsule, Solution 004184 Ribapak Ribavirin Tab DS PK 004184 Ribasphere Ribavirin Capsule, Tablet 004184 Ribatab Ribavirin Tablet, Tab DS PK 004184 Ribavirin Ribavirin Capsule, Tablet 018438 Rebetron Ribavirin/Interferon A-2B KIT 021367 Peg-Intron Peginterferon ALFA-2B KIT, PEN IJ KIT 024035 Pegasys Peginterferon ALFA-2A KIT, VIAL

Approval Criteria

1. Is peginterferon requested preferred? Yes: Go to #3. No: Go to #2.

2. Will the prescriber consider a change to a preferred Yes: Inform provider of No: Go to #3. product? covered alternatives in class Message: and proceed to #3. - Preferred products are evidence-based reviewed for http://www.dhs.state.or.us/p comparative effectiveness & safety by the Health Resources olicy/healthplan/guides/phar Commission (HRC). Reports are available at: macy/main.html http://www.oregon.gov/OHPPR/HRC/Evidence_Based_Rep orts.shtml

3. Is the request for treatment of Chronic Hepatitis C? Yes: Go to #4. No: Go to #10. Document appropriate ICD9 code: (571.40; 571.41; 571.49)

4. Is the request for continuation of therapy? (Patient has Yes: Go to “Continuation of No: Go to #5. been on HCV treatment in the preceding 12 weeks Therapy” according to the Rx profile)

5. Does the patient have a history of treatment with previous Yes: Forward to DMAP No: Go to #6. pegylated interferon-ribavirin combination treatment? Medical Director

Verify by reviewing member’s Rx profile for PEG-Intron or Pegasys, PLUS ribavirin history. Does not include prior treatment with interferon monotherapy or non-pegylated interferon.

6. Does the patient have any of the following Yes: Deny; Pass to RPH No: Go to #7. contraindications to the use of interferon-ribavirin therapy? (Medical Appropriateness) • severe or uncontrolled psychiatric disorder • decompensated cirrhosis or hepatic encephalopathy • cytopenias • untreated hyperthyroidism • severe renal impairment or transplant • autoimmune disease • pregnancy • unstable CVD

7. If applicable, has the patient been abstinent from IV drug Yes: Go to #8. No: Deny; Pass to RPH, use or alcohol abuse for ≥ 6 months? (Medical Appropriateness)

8. Does the patient have a detectable HCV RNA (viral load) Yes: Go to #9. No: Deny, Pass to RPH, > 50IU/mL? Record HCV RNA and date: (Medical Appropriateness)

9. Does the patient have a documented HCV Genotype? Yes: Approve for 16 weeks No: Deny; Pass to RPH, Record Genotype: with the following response: (Medical Your request for has been Appropriateness) approved for an initial 16 weeks. Subsequent approval is dependent on documentation of response via a repeat viral load demonstrating undetectable or 2-log reduction in HCV viral load. Please order a repeat viral load after 12 weeks submit lab results and relevant medical records with a new PA request for continuation therapy. Note: For ribavirin, approve the generic only

10. Is the request for Pegasys and the treatment of Yes: Go to #11. No: Deny; Pass to RPH, confirmed, compensated Chronic Hepatitis B? (Medical Appropriateness)

11. Is the patient currently on LAMIVUDINE (EPIVIR HBV), Yes: Deny; Pass to RPH, No: Go to #12. ADEFOVIR (HEPSERA), ENTECAVIR (BARACLUDE), (Medical Appropriateness) TELBIVUDINE (TYZEKA) and the request is for combination Pegasys-oral agent therapy?

12. Has the member received previous treatment with Yes:Deny; Pass to RPH, No: Approve Pegasys #4 pegylated interferon? (Medical Appropriateness) x 1ml vials or #4 x 0.5 ml Recommend: syringes per month for 12 LAMIVUDINE (EPIVIR HBV) months (maximum per ADEFOVIR (HEPSERA) lifetime).

Continuation of Therapy- HCV

1. Does the client have Yes: Approve as follows: No: Deny; undetectable HCV (Medical RNA or at least a 2-log Genotype Approve for Apply Appropriateness) reduction (+/- one 1 or 4 An additional 36 Ribavirin quantity limit standard deviation) in weeks or for up to a of 200 mg tablets QS# Treatment with pegylated HCV RNA measured total of 48 weeks of 180 / 25 days (for max interferon-ribarvirin does at 12 weeks? therapy (whichever is daily dose =1200 mg). not meet medical the lesser of the two). necessity criteria because 2 or 3 An additional 12 Ribavirin quantity limit there is poor chance of weeks or for up to a of 200 mg tab QS# 120 achieving an SVR. total of 24 weeks of / 25 days (for max daily therapy (whichever is dose = 800 mg). the lesser of the two). For all An additional 36 Ribavirin quantity limit genotypes weeks or for up to a of 200 mg tablets QS# and HIV total of 48 weeks of 180 / 25 days (for max co- therapy (whichever is daily dose = 1200 mg). infection the lesser of the two)

Note: Approval for beyond quantity and duration limits requires approval from the medical director.

Clinical Notes:

• Serum transaminases: Up to 40 percent of clients with chronic hepatitis C have normal serum alanine aminotransferase (ALT) levels, even when tested on multiple occasions.

• RNA: Most clients with chronic hepatitis C have levels of HCV RNA (viral load) between 100,000 (105) and 10,000,000 (107) copies per ml. Expressed as IU, these averages are 50,000 to 5 million IU. Rates of response to a course of peginterferon-ribavirin are higher in clients with low levels of HCV RNA. There are several definitions of a “low level” of HCV RNA, but the usual definition is below 800,000 IU (~ 2 million copies) per ml.(5)

• Liver biopsy: Not necessary for diagnosis but helpful for grading the severity of disease and staging the degree of fibrosis and permanent architectural damage and for ruling out other causes of liver disease, such as alcoholic liver injury, nonalcoholic fatty liver disease, or iron overload.

Stage is indicative of fibrosis: Grade is indicative of necrosis:

Stage 0 No fibrosis

Stage 1 Enlargement of the portal areas by fibrosis Stage 1 None Stage 2 Fibrosis extending out from the portal areas with rare Mild bridges between portal areas Stage 2 Stage 3 Fibrosis that link up portal and central areas of the liver Stage 3 Moderate

Stage 4 Cirrhosis Stage 4 Marked

The following are considered investigational and/or do not meet medical necessity criteria:

9 Treatment of HBV or HCV in clinically decompensated cirrhosis 9 Treatment of HCV or HBV in liver transplant recipients 9 Re-treatment of HCV or HBV previous non-responders or relapsers 9 Treatment of HCV or HBV > 48 weeks 9 Treatment of advanced renal cell carcinoma 9 Treatment of thrombocytopenia 9 Treatment of human papilloma virus 9 Treatment of multiple myeloma

DUR Board Action: 9-9-09 (DO), 9-15-05, 11-30-04, 5-25-04, Revision(s:) 1-1-10, 5-22-08 (Koder) Initiated: 1-1-07 81

Proton Pump Inhibitors (PPI) Goal(s):

¾ Promote PDL options. ¾ Restrict chronic use ( >eight weeks) to patients who failed H2-antagonist, omeprazole, Aciphex, or Prilosec OTC therapy or who have severe disease, e.g. Barrett’s, or Zollinger Ellison syndrome. ¾ Restrict BID use to patients with severe disease, H.pylori or pediatric patients.

Initiative: PPI Clinical Edit & PDL Length of Authorization: 2 weeks to lifetime (criteria specific)

Notes:

• This is a “global” PA. • If an active PA for a PPI already exists, then any PPI will pay. • A new PA is required if the dosing schedule changes, e.g., an active PA for once daily dosing restricts the PPI to once a day. • BID dosing requires a new PA, however, the strength of the dose could be increased without an additional PA, e.g, a change from 20 mg daily could be increased to 40 mg ONCE a day without an additional PA.

Covered Alternatives without PA:

9 Aciphex (HSN = 018847) 9 Prilosec OTC (HSN= 011115) 9 Omeprazole (HSN=004673) 9 H2-antagonists, sucralfate and antacids

Preferred PPIs: Listed at: http://www.oregon.gov/DHS/healthplan/tools_prov/pdl.shtml

Check the reason for the PA request: Non-Preferred drugs will deny on initiation.

ROUTE HICL BRAND GENERIC FORMULATIONS Oral 021607 Nexium Esomeprazole Capsules, delayed-release: 20, 40mg Suspension, delayed-release pkts: 10, 20, 40mg Oral 008993 Prevacid Lansoprazole Capsules, delayed-release: 15, 30 mg Enteric coated granules for oral suspension, delayed release: 15, 30mg Solu Tab: 15, 30 mg orally disintegrating tablet Oral 025742 Prevacid Lansoprazole + Delayed release capsules + naproxen tablets NapraPAC Naproxen kit - 15 – 375, 15 -500 Oral 004673 Zegerid Omeprazole Packet for solution: 20, 40mg Capsules: 20, 40mg Oral 036085 Dexilant Dexlansoprazole Capsules, delayed-release: 30, 60mg Oral 011590 Protonix Pantoprazole Tablets, delayed-release: 20 mg, 40 mg 022008 Suspension, delayed-release: 40mg Oral 011590 Pantoprazole Pantoprazole Tablets, delayed-release: 20 mg, 40 mg

Approval Criteria next page.

Approval Criteria

1. What is the diagnosis being treated? Record ICD9 code and reject/internal error code

2. Is the drug requested preferred? Yes: Go to #4. No: Go to #3.

3. Will the prescriber consider a change to a preferred Yes: Inform provider of No: Go to #4. product? covered alternatives in class. Message: http://www.dhs.state.or.us/poli • Preferred products do not require PA within cy/healthplan/guides/pharmac recommended dose limits. y/main.html • Preferred products are evidence-based reviewed for comparative effectiveness & safety by the Health Resources Commission (HRC).

Reports are available at: http://www.oregon.gov/OHPPR/HRC/Evidence_Based_R eports.shtml

4. Is diagnosis Yes: Approve for a life-time; No: Go to #5. 1. Zollinger-Ellison (251.5)? BID dosing OK. 2. Barrett’s esophagus (530.85)? 3. Multiple Endocrine Adenoma (237.4)? 4. Malignant Mastoma (202.6)? 5. MEN Type I (258.01)?

5. Is the diagnosis dyspepsia (536.8)? Yes: Pass to RPH; Deny, No: Go to #6. (OHP coverage) - Diagnosis is below the line; Prilosec OTC, Aciphex, omeprazole or H2 antagonists are available without PA.

6. Has patient tried and failed: Yes: Go to #7. No: Go to 12.

9 Omeprazole 40mg/day for 8 week trial (2 weeks for H. Pylori)?

7. Is diagnosis H.Pylori? Yes: Approve for 2 weeks – No: Go to #8. BID dosing OK

8. Is diagnosis active GI bleed? Yes: Approve for 8 weeks – No: Go to #9. (531.0-531.2, 532.0-532.2, 533.0-533.2, 534.0-534.2) BID dosing OK

Continued next page.

9. Is diagnosis Gastric or Duodenal Ulcer Yes: Approve QD for 1 year, if No: Go to #10. (531.3-531.9, 531.3-532.9, 533.3-533.9, 534.3-534.9) previously failed an 8 week and/or QD trial at highest dose does patient have 2 or more of the following risk factors: approve BID for 1 year. • > 65 years • requires > 3 mths of NSAIDs, aspirin or steroids May approve BID dosing for • on anticoagulation (warfarin, enoxapirin, etc.) pediatrics <12 years old • History of GI Bleed or Ulcer?

10. Is the diagnosis symptomatic GERD (530.81, 530.10 Yes: Approve QD dosing for 1 No: Go to #11. – 530.19) year, if previously failed an 8 week QD trial at highest dose approve BID for 1 year.

May approve BID dosing for pediatrics <12 years old

11. Is diagnosis: Yes: Approve up to BID for 1 No: Go to #13. year. a. Ulcer of esophagus (530.2x) b. Stricture & stenosis of esophagus (530.3) c. Perforation of esophagus (530.4)

12. Is the request for Prevacid Solutab for tube Yes: Approve QD dosing for 1 No: Pass to RPh. DENY administration? year. May approve BID dosing (Cost-effectivenss) for pediatrics <12years old. Recommend omeprazole 20mg QD or BID.

13. All other diagnoses will need to be evaluated by a • Diagnoses above the line and where PPI is pharmacist for appropriateness and OHP line coverage. appropriate can be covered.

• Diagnoses below the line and where PPI is appropriate should be denied as not covered.

• Diagnoses above the line but where PPIs are not appropriate should be denied and not medically appropriate.

DUR Board Action: 3/18/10 (kk), 12/03/09(DO/KK), 5-21-09; 5-7-02; 2-5-02; 9-7-01, 9-11-98 Revision(s) 04/23/10 (DO),1/1/10; 9-1-06, 7-1-06, 10-14-04, 3-1-04 Initiated:

Regranex Wound Healing Agent

Goal(s): To cover agents only for above-the-line diagnosis and those indicated by medical evidence, i.e. Restrict diabetic neuropathic ulcers.

Length of Authorization: 6 months

Requires PA: HSN GENERIC BRAND

017028 Becaplermin Regranex

Approval Criteria

1. What is the diagnosis being treated? Record ICD9 code.

2. Is the diagnosis stated as Diabetic Yes: Go to #3. No: Pass to RPH; Deny, (Medical neuropathic ulcers ? Appropriateness).

3. Does the client take any oral Yes: Approve ONLY 15 grams of No: Pass to RPH; Deny, (Medical antidiabetic meds/insulin OR has office Regranex at a time x 6 mos Appropriateness). faxed documentation of diabetic status?

DUR Board Action: Revision(s) Effective:

85 Risperdal Consta – Quantity Edit

Goal(s): To insure the use of the appropriate billing quantity.

Length of Authorization – Date of service OR 1 year, depending on criteria

PA Required: Risperdal Consta

This is a quantity initiative, not a clinical initiative. The syringe is 2 ml size . The pharmacy must submit the dispensing quantity as 1 syringe not 2 ml.

Approval Criteria

1. Is the quantity being submitted by the pharmacy expressed Yes: Go to #2. No: Have pharmacy correct to correctly as # syringes? the number of syringes instead of ml’s.

2. Is the amount requested above 2 syringes per 18 days for Yes: Approve for No: Go to #3. one of the following reasons? date of service only • Medication lost (use appropriate PA • Medication dose contaminated reason) • Increase in dose or decrease in dose • Medication stolen • Admission to a long term care facility • Any other reasonable explanation?

3. Is the pharmacy entering the dose correctly and is having to Yes: Approve for 1 Please Note: This medication dispense more than 2 syringes per 18 days due to the year. (use should NOT be denied for directions being given on a weekly basis instead of every appropriate PA clinical reasons. other week. reason)

DUR Board Action: Revision(s): 05-31-05 Effective: 11-18-04

Skeletal Muscle Relaxants

Goal(s):

¾ Cover non-preferred drugs only for above-line-line diagnosis. ¾ Restrict carisoprodol to short-term use per medical evidence. ¾ There are no long-term studies of efficacy or safety for carisoprodol. ¾ Case reports suggest it is often abused and can be fatal when used in association with opioids, benzodiazepines, alcohol or illicit drugs. ¾ Carisoprodol is metabolozied to meprobamate. ¾ See DUR Board Newsletter for more information at: Http://pharmacy.oregonstate.edu/drug_policy/pages/dur_board/newsletter/articles/volume4/4_8.html

Initiative: Skeletal Muscle Relaxant PDL & Carisoprodol Quantity Limit

Length of Authorization: Up to 6 months

Preferred Alternatives: See PDL options: http://www.oregon.gov/DHS/healthplan/tools_prov/pdl.shtml Cyclobenzaprine (similar to tricyclic antidepressants – TCAs) has the largest body of evidence supporting long-term use and is the preferred product in the muscle relaxant class. For patients that have contraindications to TCAs, NSAIDs, benzodiazepines or opioids are other alternatives. OHP does not cover pain clinic treatment.

Check the reason for the request:

• Non-Preferred drugs will deny on initiation • Carisoprodol will deny only when maximum dose exceeded

Carisoprodol product limited to Quantities >56 tablets during a rolling 90-days.

GCN GENERIC BRAND 004663, 023385 Carisoprodol Soma 004661 Carisoprodal/aspirin Soma Compound 048518 Carisoprodol/asa/codeine Soma Compound w/codeine

Approval Criteria

1. What is the diagnosis being treated? Record ICD9 code.

Yes: Got to #3. No: Pass to RPH; Deny, 2. Is diagnosis covered by the Oregon Health Plan? (Not Covered by the OHP)

3. Is drug requested carisoprodol? Yes: Go to #4. No: Go to #6.

4. Does total quantity of carisoprodol (Soma) products Yes: Go to #5. No: Quantities less than 56 exceed 56 tablets within 90 days? tablets within 90 days DO NOT require a prior From claims, document product, dose, directions, and authorization; override edit amount used during last 90 days: if needed

5. Does patient have a terminal illness (e.g. metastatic Yes: Approve for 6 months. No: Pass to RPH, Go to CA, end stage HIV, ALS)? #7.

6. Will the prescriber consider a change to a preferred Yes: Inform provider of No. Approve for up to 6 product? covered alternatives in class months Message: and carisoprodol dose limits. • Preferred products do not require PA http://www.dhs.state.or.us/p • - Preferred products are evidence-based reviewed olicy/healthplan/guides/phar for comparative effectiveness & safety by the macy/main.html Health Resources Commission (HRC).

Reports are available at: http://www.oregon.gov/OHPPR/HRC/Evidence_Based_ Reports.shtml

7. Pharmacist’s Statement: Yes: Document reason and No: Approve short taper: approve long taper: • Carisoprodol cannot be approved for long term 9 Authorize 10 usage. 9 Authorize 18 tablets tablets • Patients are limited to 56 tablets in a 90 day 9 Reduce dose over 9 9 Reduce dose over period. days 4 days • It is recommended that the patient undergo a 9 350mg TID X 3 days, 9 350 mg tid x 1 day, “taper” of the Soma (Carisoprodol) product of then then which a supply may be authorized for this to 9 350mg BID X 3 days, 9 350 mg bid x 2 occur. then days, then • The amount and length of taper depends upon 9 350mg QD x 3 days 9 350 mg QD x 1 the patent’s condition. Does the patient meet then evaluate day, then evaluate one or more of the following?: >65 years old Renal Failure Hepatic failure

Take > 1400mg per day (>3.5 tablets)

Tapering Carisoprodol

Determine history of Carisoprodol and Refill history with providers, if possible.

Does the client have renal or hepatic dysfunction, older than 65 years, or are they taking more than 1400mg per day?

NO YES

Short TAPER # 14 tabs Long TAPER #18 tabs Reduce dose over 4 days Reduce dose over 9 days 350mg TID for 3 days, then 350mg TID for 3 days, then 350mg BID for 2 days, then 350mg BID for 3 days, then 350mg QD for 1 day 350mg QD for 3 days

Is treatment still needed?

NO YES

Stop Treatment Consider NSAIDS

DUR Board Action: 9-24-09(DO),2-23-06, 2-24-04, 11-14-01, 2-21-01, 9-6-00, 5-10-00, 2-9-00 Revision(s): 1-1-10, 11-18-04 Initiated: 12-6-02

Topamax (Topiramate)

Goal(s): Approve topiramate only for covered diagnoses (above the line) that are supported by the medical literature (e.g. Epilepsy, and migraine prophylaxis).

Topiramate has not demonstrated superiority to placebo for the treatment of bipolar affective disorder. Its use should be reserved for treatment failure.

Note: Weight loss is not covered by the OHP.

Length of Authorization: 90 days to Lifetime (criteria specific)

Covered Alternatives:

Bipolar affective disorder: lithium, valproate, lamotrigine, carbamazepine, Migraine prophylaxis: tcas, beta-blockers, calcium channel blockers, valproate, Gabapentin (Refer to American Academy of Neurology Guideline (http://www.neurology.org/cgi/reprint/55/6/754.pdf )

Requires PA: Clients >18 years old; Topiramate (Topamax) HSN=011060

Approval Criteria

1. What is the diagnosis being Record the ICD9 code being treated. treated?

2. Does client have diagnosis of Yes: Approve for lifetime (until No: Go to #3. epilepsy (ICD-9 code 345.0-345.9, 12-31-2036) 780.39, or 907.0)?

3. Does the client have a diagnosis of Yes: Go to #4. No: Go to #5. migraine (ICD9 346)?

4. Has the client tried or are they Yes: Approve for 90 days with No: Pass to RPH; Deny, (Medical contraindicated to at least two of the subsequent approvals Appropriateness) and recommend trial of following drug classes: dependent on documented* covered alternative. Refer to practice • Tcas positive response for lifetime guideline • Gabapentin (12-31-2036) http://www.neurology.org/cgi/reprint/55/6/754 • Beta blockers *Documented response means .pdf • Calcium channel blockers that follow-up and response is • Valproate noted in client’s chart per clinic staff Document drugs tried or contraindications.

5. Does the client have a diagnosis of Yes: Go to #6. No: Go to #7. bipolar affective disorder or schizoaffective disorder (ICD9 296 and subsets)? (ICD9 2965(?) And subsets)?

6. Has the client tried or are they Yes: Approve for 90 days with No: PASS TO RPH, DENY(Medical contraindicated to at least two of the subsequent approvals Appropriateness) and recommend trial of following drugs: dependent on documented covered alternative. • Lithium positive response for lifetime • Valproate and derivatives approval.* • Lamotrigine • Carbamazepine • Atypical antipsychotic

Document drugs tried or contraindications.

7. Is the client using the medication Yes: Pass to RPH; Deny, (Not No: Go to #8. for weight loss? (Obesity ICD9 278.0, covered by the OHP) 278.01)?

8. Pass to RPH.

All other indications need to be evaluated for Use is off-label: Deny, (Medical Appropriateness) Other appropriateness: treatments should be tried as appropriate.

Neuropathic pain Below the line diagnoses: Deny, (Not covered by the Post-Traumatic Stress Disorder (PTSD) OHP) Substance abuse If clinically warranted: Deny, yesterdays date (Medical Appropriateness) and use clinical judgement to approve for 1 month starting today to allow time for appeal.

MESSAGE: ”Although the request has been denied for long term use because it is considered medically inappropriate, it has also been APPROVED for one month to allow time for appeal.”

DUR Board Action: (9-20-2007, 11-29-2007) Revision(s): Initiated: 4/1/08

91 Weight Loss Medications

Goal(s):

¾ Cover drugs only for covered diagnoses.

¾ Obesity treatment is generally not covered by the OHP and amphetamines are NOT covered for weight loss.

OREGON Medicaid restricts access to Orlistat for weight loss, but CMS states Medicaid programs must make it available for hypercholesterolemia.

Note: For Weight Loss Fax Questionnaire

Length of Authorization: 4 months, (ONCE IN A LIFETIME)

HSN Generic Name 018751 Orlistat 016924 Sibutramine 002070 Benzphetamine 002112 Phentermin Resin 002116 Diethylpropion 002111 Phentermine 002115 Bontril

Approval Criteria

1. What is the diagnosis being treated? Record the ICD9 code being treated.

2. Is the diagnosis obesity or weight Yes: Go to #3. No: Go to #4. related?

3. Client requesting weight reduction drugs must meet the following four requirements (A.B.C. & D):

A. Does the client have documented Yes: Proceed with next question diagnosis of Diabetes Mellitus?

• Does the client have Yes: Document medication(s) used documented anti-diabetic and No: Pass to RPH: Deny, (Not medications on their profile? Go to B. Covered by the OHP)

B. Does client have hyperlipidemia? Yes: Proceed with next question

• Does client have documented Yes: Proceed with next question lipid-lowering therapy on profile?

• Request clients last serum LDL cholesterol concentration

• Is LDL > 160mg/dl Yes: Go to C.

Is the client obese? Go to C. Yes: D. • Document height, Document weight:(see charts below) No: Pass to RPH: Deny, (Not Covered by the OHP) D. Is the client on a 1200 calorie or Yes: Approve weight less diet? Loss medication for four (4) months: NOTE: THIS IS NOT RENEWABLE- THIS IS A LIFETIME LIMIT OF FOUR MONTHS

92 4. Is Orlistat being used to treat Yes: Go to #5. No: Pass to RPH; Deny, (Medical hypercholesterolemia? (OREGON Appropriateness) Medicaid restricts access to orlistat for weight loss, but CMS states Medicaid programs must make it available for hypercholesterolemia).

5. Has client failed or is intolerant to Statin, Yes: Approve for 3 month with No: Pass to RPH and suggest fibrate, or bile acid sequestrant therapy? subsequent approvals (up to 1 year) alternatives; generic lovastatin is dependent on favorable response. the preferred statin. If not willing switch, approve for 3 month with subsequent approvals (up to 1 year) dependent on favorable response.

Source: Evidence Report of Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults, 1998, National Institutes of Health, National Hart, Lung, and Blood Institute, http;//www.health.gove/dietaryguidelines/dga2005/document/html/hcapter3.htm

DUR Board Action: Revisions: 7-1-06 Initiation:

93 Oregon Pharmacy Call Center Phone: 888-202-2126 Fax: 888-346-0178

WEIGHT REDUCTION QUESTIONNAIRE

Please answer all questions and reply within 3 business days. Thank You.

PRESCRIBING PHYSICIAN: DMAP CLIENT:

Name: ______Name: ______First Last First Last OR Medicaid ID (6 digits): ______Date of Birth: ______

Phone #: ______Recipient ID (8 characters): ______

Fax #: ______Request Date: ______

Office Contact: ______a PARTICIPATING PHARMACY: a Name: ______Phone: ______

Name of Product and Strength: ______i Corrections and Quantity: ______a Client’s current weight: ______lbs/kg Date Taken: ______a Client’s Height (if wheelchair or bed bound, an estimate is necessary): ______

All applicable ICD-9 code: ______

Is the client on a 1200 calorie or less diet? ______

Does the client have Diabetes Mellitus (Type I or II)? ______If yes, what medications is the client currently on? ______

Does the client have Hyperlipidemia? ______If yes, what medications is the client currently on? ______What is the client’s last serum LDL cholesterol conc.? ______When taken?______

Physician’s Signature: ______